[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58488-58489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24625]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-M-2375, FDA-2015-M-0909, FDA-2015-M-0199, FDA-
2015-M-0200, FDA-2015-M-0201, FDA-2015-M-0228, FDA-2015-M-0266, FDA-
2015-M-0267, FDA-2015-M-0431, FDA-2015-M-0502, FDA-2015-M-0690, FDA-
2015-M-0738, FDA-2015-M-0910]
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) is publishing a list of
premarket approval applications (PMAs) that have been approved. 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 Division of Dockets Management.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT: Melissa Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-5576.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the 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 placed on the Internet. 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 quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from January 1, 2015, through March 31,
2015. 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 Made Available From January 1, 2015,
Through March 31, 2015
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P980040/S049, FDA-2014-M-2375....... Abbott Medical Optics, Inc.. TECNIS[supreg] multifocal 1- 12/17/2014
piece intraocular lens.
P140010, FDA-2015-M-0199............ Medtronic, Inc.............. IN.PACTTM AdmiralTM 12/30/2014
Paclitaxel-coated
Percutaneous Transluminal
Angioplasty Balloon
Catheter.
P130019, FDA-2015-M-0201............ EnteroMedics, Inc........... Maestro[supreg] Rechargeable 1/14/2015
System.
P130025, FDA-2015-M-0200............ Koning Corp................. Koning Breast CT (Model CBCT 1/14/2015
1000).
P060001/S020, FDA-2015-M-0228....... ev3, Inc.................... Prot[eacute]g[eacute]TM GPS 1/21/2015
Self-Expanding Peripheral
Stent System.
H140001, FDA-2015-M-0267............ ABIOMED, Inc................ Impella RP System........... 1/23/2015
[[Page 58489]]
P140017, FDA-2015-M-0266............ Medtronic, Inc.............. MelodyTM Transcatheter 1/27/2015
Pulmonary Valve (TPV) and
EnsembleTM Transcatheter
Valve Delivery System.
P130023, FDA-2015-M-0431............ Cohera Medical, Inc......... TissuGlu[supreg] Surgical 2/3/2015
Adhesive.
P010047/S036, FDA-2015-M-0502....... NeoMend, Inc................ ProGelTM Pleural Air Leak 2/13/2015
Sealant.
P140018, FDA-2015-M-0690............ Covidien, LLC............... VenaSealTM Closure System... 2/20/2015
H130001, FDA-2015-M-0909............ Biologics Consulting Group, Lixelle Beta 2-microglobulin 3/5/2015
Inc.. Apheresis Column.
P110024, FDA-2015-M-0738............ Advanced Circulatory ResQCPRTM System............ 3/6/2015
Systems, Inc..
P130013, FDA-2015-M-0910............ Boston Scientific Corp...... WATCHMANTM Left Atrial 3/13/2015
Appendage (LAA) Closure
Technology.
----------------------------------------------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24625 Filed 9-28-15; 8:45 am]
BILLING CODE 4164-01-P