[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]
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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.
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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