[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15686-15691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06052]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-
2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-
2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-
2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-
2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-
2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-
2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-
2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-
2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-M-2522, FDA-2019-M-
2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-2019-M-
2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-2019-M-
3652, FDA-2019-M-3845, FDA-2019-M-3863, FDA-2019-M-3844, FDA-2019-M-
4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-4238, FDA-2019-M-
4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-5438, FDA-2019-M-
5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-5741, FDA-2019-M-
5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-0107, FDA-2020-M-
0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-0984, FDA-2020-M-
0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-1116, FDA-2020-M-
1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-1267, FDA-2020-M-
1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-1300, FDA-2020-M-
1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-1410, FDA-2020-M-
1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-1600, FDA-2020-M-
1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-1724, FDA-2020-M-
1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-1760, FDA-2020-M-
1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-1828, FDA-2020-M-
1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-1838, FDA-2020-M-
1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-2288, FDA-2020-M-
2248, and FDA-2020-M-2339]


Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing 
a list of premarket approval applications (PMAs) that have been 
approved from October 1, 2018, through December 31, 2020. This list is 
intended to inform the public of the availability of safety and 
effectiveness summaries of approved PMAs through the internet and the 
Agency's Dockets Management Staff.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033, 
FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-

[[Page 15687]]

2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-
2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-
2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-
2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-
2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-
2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-
2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-2019-M-2522, FDA-
2019-M-2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-
2019-M-2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-
2019-M-3652, FDA-M-3845, FDA-2019-M-3862, FDA-2019-M-3863, FDA-2019-M-
3844, FDA-2019-M-4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-
4238, FDA-2019-M-4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-
5438, FDA-2019-M-5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-
5741, FDA-2019-M-5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-
0107, FDA-2020-M-0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-
0984, FDA-2020-M-0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-
1116, FDA-2020-M-1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-
1267, FDA-2020-M-1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-
1300, FDA-2020-M-1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-
1410, FDA-2020-M-1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-
1600, FDA-2020-M-1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-
1724, FDA-2020-M-1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-
1760, FDA-2020-M-1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-
1828, FDA-2020-M-1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-
1838, FDA-2020-M-1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-
2288, FDA-2020-M-2248, and FDA-2020-M-2339 for ``Medical Devices; 
Availability of Safety and Effectiveness Summaries for Premarket 
Approval Applications.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Dharmesh Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and 
(e)(2)), notification of an order approving, denying, or withdrawing 
approval of a PMA will continue to include a notice of opportunity to 
request review of the order under section 515(g) of the FD&C Act. The 
30-day period for requesting reconsideration of an FDA action under 
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a 
PMA begins on the day the notice is published in the Federal Register. 
Section 10.33(b) provides that FDA may, for good cause, extend this 30-
day period. Reconsideration of a denial or withdrawal of approval of a 
PMA may be sought only by the applicant; in these cases, the 30-day 
period will begin when the applicant is notified by FDA in writing of 
its decision.
    The regulations provide that FDA publish a list of available safety 
and effectiveness summaries of PMA approvals and denials that were 
announced. The following is a list of approved PMAs for which summaries 
of safety and effectiveness were placed on the internet from October 1, 
2018, through December 31, 2020. There were no denial actions during 
this period. The list provides the manufacturer's name, the product's 
generic name or the trade name, and the approval date.

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs and Safety and Probable Benefit Summaries
                for Approved HDEs Made Available From October 1, 2018, Through December 31, 2020
----------------------------------------------------------------------------------------------------------------
          PMA No., Docket No.                   Applicant                   Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P180003, FDA-2018-M-3841..............  Veryan Medical Ltd......  BioMimics 3D Vascular Stent          10/4/2018
                                                                   System.
P150040/S003, FDA-2018-M-3842.........  Carl Zeiss Meditec, Inc.  VisuMax Femtosecond Laser....        10/4/2018
P160054/S008, FDA-2018-M-3983.........  Thoratec Corp...........  HeartMate 3 Left Ventricular        10/18/2018
                                                                   Assist System.
P100040/S036, FDA-2018-M-4033.........  Medtronic Vascular......  Valiant NavionTM Thoracic           10/19/2018
                                                                   Stent Graft System.
P180010, FDA-2018-M-4205..............  W.L. Gore & Associates,   GORE Carotid Stent...........        11/1/2018
                                         Inc.
P150002, FDA-2018-M-4580..............  Cordis Corp.............  Cordis INCRAFT[supreg] AAA          11/27/2018
                                                                   Stent Graft System.

[[Page 15688]]

 
P120016/S024, FDA-2018-M-4582.........  Cardiva Medical, Inc....  VASCADE[supreg] MVP Venous          11/27/2018
                                                                   Vascular Closure System.
P180007, FDA-2018-M-4665..............  Spiration, Inc..........  Spiration[supreg] Valve              12/3/2018
                                                                   System.
P160034, FDA-2018-M-4672..............  Cardiac Science Corp....  Powerheart[supreg] G3 Pro AED        12/6/2018
P160033, FDA-2018-M-4675..............  Cardiac Science Corp....  Powerheart[supreg] G5 AED,           12/7/2018
                                                                   Powerheart[supreg] AED G3
                                                                   Plus, And Powerheart[supreg]
                                                                   AED G3.
P160043/S012, FDA-2018-M-4777.........  Medtronic Vascular......  Resolute OnyxTM Zotarolimus-        12/14/2018
                                                                   Eluting Coronary Stent
                                                                   System.
P110013/S088, FDA-2018-M-4778.........  Medtronic Vascular......  Resolute Integrity                  12/14/2018
                                                                   Zotarolimus-Eluting Coronary
                                                                   Stent System.
P100018/S015, FDA-2018-M-4779.........  Micro Therapeutics, Inc.  PipelineTM Flex Embolization        12/14/2018
                                         d/b/a ev3 Neurovascular.  Device.
P150038/S006, FDA-2018-M-4780.........  InSightec, Inc..........  Exablate Model 4000 Types 1.0       12/16/2018
                                                                   and 1.1 System (Exablate
                                                                   Neuro).
P170018, FDA-2018-M-4916..............  Physio-Control, Inc.....  LIFEPAK[supreg] CR2                 12/21/2018
                                                                   Defibrillator.
P170032, FDA-2019-M-0027..............  Sequent Medical, Inc....  Woven EndoBridge (WEB)              12/31/2018
                                                                   Aneurysm Embolization System.
P180001, FDA-2019-M-0028..............  William Cook Europe ApS.  Zenith[supreg] Dissection           12/31/2018
                                                                   Endovascular System.
P170037, FDA-2019-M-0505..............  OPKO Diagnostics, LLC...  Sangia Total PSA Test........        1/30/2019
P180025, FDA-19M-2526.................  Essential Medical, Inc..  MANTATM Vascular Closure              2/1/2019
                                                                   Device.
P170036, FDA-2019-M-0645..............  Spinal Kinetics LLC.....  M6-CTM Artificial Cervical            2/6/2019
                                                                   Disc.
P160050, FDA-2019-M-0802..............  Intrinsic Therapeutics..  Barricaid[supreg] Anular              2/8/2019
                                                                   Closure Device (ACD).
P170030, FDA-2019-M-0885..............  Biotronik, Inc..........  Orsiro Sirolimus Eluting             2/22/2019
                                                                   Coronary Stent System
                                                                   (Orsiro Stent System).
P170042/S002, FDA-2019-M-0995.........  C.R. Bard, Inc..........  COVERATM Vascular Covered             3/1/2019
                                                                   Stent.
P160002/S009, FDA-2019-M-1310.........  Ventana Medical System,   VENTANA PD-L1 (SP142) Assay..         3/8/2019
                                         Inc.
P180037, FDA-2019-M-1214..............  Bard Peripheral           VENOVO Venous Stent System...        3/13/2019
                                         Vascular, Inc. (BPV).
P100009/S028, FDA-2019-M-1251.........  Abbott Vascular, Inc....  MitraClip NT Clip Delivery           3/14/2019
                                                                   System; MitraClip NTR/XTR
                                                                   Clip Delivery System.
P180036, FDA-2019-M-1313..............  Impulse Dynamics (USA),   OPTIMIZER Smart System.......        3/21/2019
                                         Inc.
P180040, FDA-2019-M-1465..............  Fidia Pharma USA, Inc...  TRILURONTM...................        3/26/2019
P180032, FDA-2019-M-1506..............  Channel Medsystems, Inc.  Cerene[supreg] Cryotherapy           3/28/2019
                                                                   Device.
P170027, FDA-2019-M-1582..............  TherOx, Inc.............  TherOx DownStream System.....         4/2/2019
P180034, FDA-2019-M-1763..............  Intact Vascular, Inc....  Tack Endovascular                    4/11/2019
                                                                   System[supreg] (6F).
P180043, FDA-2019-M-1979..............  QIAGEN Manchester Ltd...  therascreen[supreg] FGFR RGQ         4/12/2019
                                                                   RT-PCR Kit.
P180024, FDA-2019-M-1848..............  BAROnova, Inc...........  TransPyloric Shuttle/                4/16/2019
                                                                   TransPyloric Shuttle
                                                                   Delivery Device.
P180029, FDA-2019-M-1998..............  Boston Scientific Corp..  LOTUS EdgeTM Valve System....        4/23/2019
P180014, FDA-2019-M-2052..............  XVIVO Perfusion, Inc....  XVIVO Perfusion System               4/26/2019
                                                                   (XPSTM) with STEEN
                                                                   SolutionTM Perfusate.
P180013, FDA-2019-M-2193..............  Boston Scientific Corp..  VICI VENOUS STENT[supreg]             5/2/2019
                                                                   System.
P180031, FDA-2019-M-2408..............  Stryker Neurovascular...  Neuroform Atlas[supreg] Stent        5/16/2019
                                                                   System.
H180002, FDA-2019-M-2522..............  Novocure, Ltd...........  NovoTTFTM-100L System........        5/23/2019
P190001, FDA-2019-M-2560..............  QIAGEN GmbH.............  therascreen PIK3CA RGQ PCR           5/24/2019
                                                                   Kit.
P190004, FDA-2019-M-2561..............  QIAGEN GmbH.............  therascreen PIK3CA RGQ PCR           5/24/2019
                                                                   Kit.
P160013/S002, FDA-2019-M-2671.........  TransMedics, Inc........  Organ Care System (OCSTM)            5/31/2019
                                                                   Lung System.
P160036, FDA-2019-M-2732..............  DT MedTech, LLC.........  Hintermann Series H3TM Total          6/4/2019
                                                                   Ankle Replacement System.
P160048/S006, FDA-2019-M-2753.........  Senseonics, Inc.........  Eversense Continuous Glucose          6/6/2019
                                                                   Monitoring System.
P160029, FDA-2019-M-2782..............  Philips Medical Systems,  HeartStart OnSite                     6/6/2019
                                         Inc.                      Defibrillator (Model
                                                                   M5066A), HeartStart Home
                                                                   Defibrillator (Model
                                                                   M5068A), Primary Battery
                                                                   (Model M5070A), SMART Pads
                                                                   Cartridges (Adult Model
                                                                   M5071A) and Infant/Child
                                                                   (Model M5072A).
P150013/S014, FDA-2019-M-3309.........  Dako North America, Inc.  PD-L1 IHC 22C3 pharmDx.......        6/10/2019
P000025/S104, FDA-2019-M-3513.........  MED-EL Corp.............  MED-EL Cochlear Implant              7/19/2019
                                                                   System.
P150013/S016, FDA-2019-M-3652.........  Dako North America, Inc.  PD-L1 1HC 22C3 pharmDx.......        7/30/2019
P140031/S085, FDA-2019-M-3845.........  Edwards Lifesciences LLC  Edwards SAPIEN 3                     8/16/2019
                                                                   Transcatheter Heart Valve
                                                                   System and Edwards SAPIEN 3
                                                                   Ultra Transcatheter Heart
                                                                   Valve System.
H190005, FDA-2019-M-3863..............  Zimmer Biomet Spine, Inc  The TetherTM--Vertebral Body         8/16/2019
                                                                   Tethering System.
P180050, FDA-2019-M-3862..............  CVRx, Inc...............  BAROSTIM NEO[supreg] System..        8/16/2019
P130021/S058, FDA-2019-M-3844.........  Medtronic CoreValve LLC.  Medtronic CoreValve Evolut R         8/16/2019
                                                                   System and Medtronic
                                                                   CoreValve Evolut PRO System.
H170001, FDA-2019-M-4007..............  ApiFix, Ltd.............  Minimally Invasive Deformity           8/23/19
                                                                   Correction (MID-C) System.

[[Page 15689]]

 
P040020/S087, FDA-2019-M-4153.........  Alcon Laboratories, Inc.  AcrySof[supreg] IQ                   8/26/2019
                                                                   PanOptix[supreg] Trifocal
                                                                   Intraocular Lens (Model
                                                                   TFNT00) and AcrySof[supreg]
                                                                   IQ PanOptix[supreg] Toric
                                                                   Trifocal Intraocular Lens
                                                                   (Models TFNT30, TFNT40,
                                                                   TFNT50 and TFNT60).
P190006, FDA-2019-M-4186..............  Axonics Modulation        Axonics Sacral                        9/6/2019
                                         Technologies, Inc.        Neuromodulation System.
P930016/S057, FDA-2019-M-4238.........  AMO Manufacturing USA,    iDESIGN[supreg] Refractive            9/9/2019
                                         LLC.                      Studio and STAR S4
                                                                   IR[supreg] Excimer Laser
                                                                   Systems.
P190011, FDA-2019-M-4928..............  DiaSorin Inc............  LIAISON XL MUREX HCV Ab             10/18/2019
                                                                   LIAISON XL MUREX Control HCV
                                                                   Ab.
P190014, FDA-2019-M-4978..............  Myriad Genetic            Myriad myChoice[supreg] CDx..       10/23/2019
                                         Laboratories, Inc.
P180046, FDA-2019-M-5393..............  Axonics Modulation        Axonics Sacral                      11/13/2019
                                         Technologies, Inc.        Neuromodulation System.
P180035, FDA-2019-M-5438..............  CooperVision, Inc.......  MiSight 1 Day (omafilcon A)         11/15/2019
                                                                   Soft (Hydrophilic) Contact
                                                                   Lenses for Daily Wear.
P190008, FDA-2019-M-5534..............  Medtronic, Inc..........  IN.PACTTM AV Paclitaxel-            11/21/2019
                                                                   coated Percutaneous
                                                                   Transluminal Angioplasty
                                                                   (PTA) Balloon Catheter.
P190016, FDA-2019-M-5605..............  Tusker Medical, Inc.....  Tula[supreg] System..........       11/25/2019
P180047, FDA-2019-M-5683..............  DiaSorin, Inc...........  LIAISON QuantiFERON--TB Gold        11/26/2019
                                                                   Plus, LIAISON Control
                                                                   QuantiFERON--TB Gold Plus
                                                                   and LIAISON QuantiFERON
                                                                   Software.
P170019/S006, FDA-2019-M-5741.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx....        12/3/2019
P170038, FDA-2019-M-5857..............  Abbott..................  CentriMag Circulatory Support        12/6/2019
                                                                   System.
P180027, FDA-2019-M-5961..............  MicroVention, Inc.......  Flow Re-Direction Endoluminal       12/16/2019
                                                                   Device (FRED[supreg]) System.
P140009/S039, FDA-2020-M-0097.........  Abbott Medical, Inc.....  Abbott InfinityTM DBS System.         1/2/2020
P180038, FDA-2020-M-0107..............  DiaSorin, Inc...........  LIAISON[supreg] XL MUREX Anti-        1/2/2020
                                                                   HBc, LIAISON[supreg] XL
                                                                   MUREX Control Anti-HBc.
P190018, FDA-2020-M-0108..............  Alcon Research, Inc.....  ClareonTM Aspheric                    1/7/2020
                                                                   Hydrophobic Acrylic
                                                                   Intraocular Lens (IOL)
                                                                   (Model Number: SY60WF);
                                                                   ClareonTM Toric Aspheric
                                                                   Hydrophobic Acrylic
                                                                   Intraocular Lens (IOL)
                                                                   (Model Numbers: CNW0T3,
                                                                   CNW0T4, CNW0T5, CNW0T6,
                                                                   CNW0T7, CNW0T8 and CNW0T9);
                                                                   ClareonTM Aspheric
                                                                   Hydrophobic Acrylic
                                                                   Intraocular Lens (IOL) with
                                                                   the AutonoMeTM Pre-loaded
                                                                   Delivery System (Model
                                                                   Number: CNA0T0); ClareonTM
                                                                   Toric Aspheric Hydrophobic
                                                                   Acrylic Intraocular Lens
                                                                   (IOL) with the AutonoMeTM
                                                                   Pre-loaded Delivery System
                                                                   (Model Numbers: CNA0T3,
                                                                   CNA0T4, CNA0T5, CNA0T6,
                                                                   CNA0T7, CNA0T8 and CNA0T9).
P170023, FDA-2020-M-0495..............  Contura International A/  Bulkamid[supreg] Urethral            1/28/2020
                                         S.                        Bulking System.
P170022, FDA-2020-M-0985..............  ARJ Medical, Inc........  PyloPlus UBT System..........        2/18/2020
P180039, FDA-2020-M-0984..............  DiaSorin Inc............  LIAISON[supreg] XL MUREX Anti-       2/21/2020
                                                                   HBs; LIAISON[supreg] XL
                                                                   MUREX Control Anti-HBs;
                                                                   LIAISON[supreg] XL MUREX
                                                                   Anti-HBs Verifiers.
P930014/S126, FDA-2020-M-0986.........  Alcon Laboratories, Inc.  AcrySofTM IQ VivityTM                2/26/2020
                                                                   Extended Vision Intraocular
                                                                   Lens (Model DFT015);
                                                                   AcrySofTM IQ VivityTM Toric
                                                                   Extended Vision IOLs
                                                                   (DFT315, DFT 415, DFT515);
                                                                   AcrySofTM IQ VivityTM
                                                                   Extended Vision UV Absorbing
                                                                   IOL (DAT015); AcrySofTM IQ
                                                                   VivityTM Toric Extended
                                                                   Vision UV Absorbing IOLs
                                                                   (DAT315, DAT415, DAT515).
P190024, FDA-2020-M-1083..............  Ventana Medical Systems,  CINtec[supreg] PLUS Cytology.        3/10/2020
                                         Inc.
P120006/S031, FDA-2020-M-1126.........  Endologix, Inc..........  AltoTM Abdominal Stent Graft         3/13/2020
                                                                   System.
P980033/S050, FDA-2020-M-1115.........  Boston Scientific Corp..  VENOUS WALLSTENT.............        3/17/2020
P970051/S172, FDA-2020-M-1116.........  Cochlear Americas.......  Nucleus 24 Cochlear Implant          3/17/2020
                                                                   System.
P190025, FDA-2020-M-1175..............  Abbott Molecular, Inc...  Alinity m HCV................        3/23/2020
P140029/S021, FDA-2020-M-1214.........  Q-Med AB, a Galderma      Restylane[supreg] Kysse......        3/26/2020
                                         affiliate.
P190028, FDA-2020-M-1213..............  Roche Molecular Systems,  cobas HPV for use on the              4/3/2020
                                         Inc.                      cobas 6800/8800 Systems.
P190027, FDA-2020-M-1286..............  Intact Vascular, Inc....  Tack Endovascular                    4/10/2020
                                                                   System[supreg] (4F, 1.5-
                                                                   4.5mm).
P050010/S020, FDA-2020-M-1267.........  Centinel Spine, LLC.....  prodisc[supreg] L Total Disc         4/10/2020
                                                                   Replacement.
P130008/S039, FDA-2020-M-1299.........  Inspire Medical Systems,  Inspire[supreg] Upper Airway         4/14/2020
                                         Inc.                      Stimulation (UAS).

[[Page 15690]]

 
P190026, FDA-2020-M-1290..............  QIAGEN GmbH.............  therascreen[supreg] BRAF             4/15/2020
                                                                   V600E RGQ PCR Kit.
P170019/S013, FDA-2020-M-1300.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx            4/17/2020
                                                                   (F1CDx).
P190015, FDA-2020-M-1311..............  Bolton Medical Inc......  TREO[supreg] Abdominal Stent-         5/4/2020
                                                                   Graft System.
P170019/S011, FDA-2020-M-1358.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx             5/6/2020
                                                                   (F1CDx).
P160028, FDA-2020-M-1367..............  Philips Medical Systems,  HeartStart FR3 Defibrillators        5/11/2020
                                         Inc.                      Models 861388 (Text) and
                                                                   861389 (ECG Display),
                                                                   Primary Battery (Models
                                                                   989803150161, 989803150171),
                                                                   Rechargeable Battery (Model
                                                                   989803150241), Charger for
                                                                   the Rechargeable Battery
                                                                   (Model 861394), SmartPads
                                                                   III (Models 989803149981,
                                                                   989803149991), DP pads
                                                                   (Models 989803158211,
                                                                   989803158221), and Pediatric
                                                                   Key (Model 989803150031).
P180028, FDA-2020-M-1368..............  Philips Medical Systems,  HeartStart FRx Defibrillator         5/11/2020
                                         Inc.                      (861304), Primary Battery
                                                                   (M5070A), Aviation FRx
                                                                   Battery (989803139301),
                                                                   SMART Pads II
                                                                   (989803139261), and Infant/
                                                                   Child Key (989803139311).
P150025/S013, FDA-2020-M-1410.........  Dako North America, Inc.  PD-L1 IHC 28-8 pharmDx.......        5/15/2020
P170019/S015, FDA-2020-M-1420.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx....        5/19/2020
P110033/S047, FDA-2020-M-1527.........  Allergan................  JUV[Eacute]DERM[supreg]              6/12/2020
                                                                   VOLUMATM XC.
P190021, FDA-2020-M-1583..............  Mainstay Medical Ltd....  ReActiv8 Implantable                 6/16/2020
                                                                   Neurostimulation System.
P170019/S016, FDA-2020-M-1612.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx            6/16/2020
                                                                   (F1CDx).
P200014, FDA-2020-M-1600..............  Roche Molecular Systems,  cobas[supreg] EZH2 Mutation          6/18/2020
                                         Inc.                      Test.
P100010/S098, FDA-2020-M-1613.........  Medtronic, Inc..........  Arctic Front AdvanceTM               6/23/2020
                                                                   Cardiac Cryoablation
                                                                   Catheter Arctic Front
                                                                   Advance ProTM Cardiac
                                                                   Cryoablation Catheters
                                                                   FreezorTM MAX Cardiac
                                                                   Cryoablation Catheter
                                                                   CryoConsole Manual
                                                                   Retraction Kit.
P130013/S035, FDA-2020-M-1715.........  Boston Scientific Corp..  WATCHMAN FLX Left Atrial             7/21/2020
                                                                   Appendage Closure Device
                                                                   with Delivery System and
                                                                   WATCHMAN Left Atrial
                                                                   Appendage Closure Device
                                                                   with Delivery System.
P190031, FDA-2020-M-1724..............  Ventana Medical Systems,  VENTANA HER2 Dual ISH DNA            7/28/2020
                                         Inc.                      Probe Cocktail.
P180031/S001, FDA-2020-M-1726.........  Stryker Neurovascular...  Neuroform Atlas[supreg] Stent        7/30/2020
                                                                   System.
P200010, FDA-2020-M-1748..............  Guardant Health, Inc....  Guardant360[supreg] CDx......         8/7/2020
P190007, FDA-2020-M-1752..............  Cardinal Health.........  KendallTM Multi-Function              8/7/2020
                                                                   Defibrillation Electrodes,
                                                                   Medi-TraceTM Cadence Multi-
                                                                   Function Defibrillation
                                                                   Electrodes, Physio-Control/
                                                                   Stryker QUIK-COMBO Pacing/
                                                                   Defibrillation/ECG
                                                                   Electrodes.
P150003/S058, FDA-2020-M-1760.........  Boston Scientific Corp..  SYNERGYTM Everolimus-Eluting         8/10/2020
                                                                   Platinum Chromium Coronary
                                                                   Stent System (MonorailTM);
                                                                   SYNERGYTM Everolimus-Eluting
                                                                   Platinum Chromium Coronary
                                                                   Stent System (Over-The-
                                                                   WireTM); SYNERGYTM XD
                                                                   Everolimus-Eluting Platinum
                                                                   Chromium Coronary Stent
                                                                   System (MonorailTM).
P190032, FDA-2020-M-1821..............  Foundation Medicine, Inc  FoundationOne Liquid CDx.....        8/26/2020
P180048, FDA-2020-M-1783..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX             8/29/2020
                                                                   HBeAg, LIAISON[supreg] XL
                                                                   MUREX Control HBeAg.
P180049, FDA-2020-M-1822..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX anti-       8/29/2020
                                                                   HBe, LIAISON[supreg] XL
                                                                   MUREX Control Anti-HBe.
P180045, FDA-2020-M-1828..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX HBc         8/29/2020
                                                                   IgM, LIAISON[supreg] XL
                                                                   MUREX Control HBc IgM.
P200013, FDA-2020-M-1830..............  Abbott Molecular, Inc...  Alinity m HBV................        8/29/2020
P190017, FDA-2020-M-1829..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX             8/29/2020
                                                                   HBsAg Qual; LIAISON[supreg]
                                                                   MUREX Control HBsAg Qual;
                                                                   LIAISON[supreg] XL MUREX
                                                                   HBsAg Confirmatory Test.
P200015, FDA-2020-M-1835..............  Edwards Lifesciences,     Edwards SAPIEN 3                     8/31/2020
                                         LLC.                      Transcatheter Heart Valve
                                                                   System with Edwards
                                                                   Commander Delivery System.
P160017/S076, FDA-2020-M-1838.........  Medtronic Minimed, Inc..  MiniMed 770G System..........        8/31/2020
P140031/S112, FDA-2020-M-1868.........  Edwards Lifesciences,     Edwards SAPIEN 3 and SAPIEN 3         9/9/2020
                                         LLC.                      Ultra Transcatheter Heart
                                                                   Valve System.
P200022, FDA-2020-M-1986..............  Simplify Medical, Inc...  Simplify[supreg] Cervical            9/18/2020
                                                                   Artificial Disc.
P160042/S010, FDA-2020-M-2021.........  Prollenium Medical        Revanesse[supreg] Lips+......        9/21/2020
                                         Technologies, Inc.

[[Page 15691]]

 
H190001, FDA-2020-M-2248..............  HDL Therapeutics, Inc...  Plasma Delipidation System           12/1/2020
                                                                   (PDS-2TM System).
P190030, FDA-2020-M-2288..............  Theragen, Inc...........  ActaStim-S Spine Fusion                12/9/20
                                                                   Stimulator.
P200030, FDA-2020-M-2339..............  W. L. Gore and            GORE[supreg] EXCLUDER[supreg]         12/22/20
                                         Associates, Inc.          Conformable AAA
                                                                   Endoprosthesis (EXCC).
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the internet may obtain the documents at 
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: March 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06052 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P