[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7615-7616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02783]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-M-0867, FDA-2014-M-0874, FDA-2014-M-0875, FDA-
2014-M-1060, FDA-2014-M-1064, FDA-2014-M-1113, FDA-2014-M-1114, FDA-
2014-M-1193, FDA-2014-M-1265, FDA-2014-M-1279, and FDA-2014-M-1280]
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) 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: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.
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 July 1, 2014, through September 30,
2014. 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 July 1, 2014, Through
September 30, 2014
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PMA No., Docket No. Applicant Trade name Approval date
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P130021/S002, FDA-2014-M-0867...... Medtronic CoreValve Medtronic CoreValveTM June 12, 2014.
LLC. System (MCS).
P130009, FDA-2014-M-0874........... Edwards Lifesciences, Edwards SAPIEN XTTM June 16, 2014.
LLC. Transcatheter Heart
Valve and
Accessories.
P130029, FDA-2014-M-0875........... Bard Peripheral Fluency[supreg] Plus June 17, 2014.
Vascular, Inc. Endovascular Stent
Graft.
P130011, FDA-2014-M-1064........... Sorin Group Canada, Freedom SOLO June 24, 2014.
Inc. Stentless Heart
Valve and SOLO Smart
Heart Valve.
P130030, FDA-2014-M-1060........... Boston Scientific REBELTM Platinum June 27, 2014.
Corp. Chromium Coronary
Stent System
(MonorailTM and Over-
The-Wire).
P090029, FDA-2014-M-1113........... Medtronic Sofamor Prestige[supreg] LP July 24, 2014.
Danek USA, Inc. Cervical Disc.
H130005, FDA-2014-M-1114........... MicroVention, Inc.... Low-Profile July 25, 2014.
Visualized
Intraluminal Support
Device (LVIS and
LVIS Jr.).
P130017, FDA-2014-M-1193........... Exact Sciences, Inc.. COLOGUARDTM.......... August 11, 2014.
H120003, FDA-2014-M-1265........... XVIVO Perfusion, Inc. XVIVO Perfusion August 12, 2014.
System (XPSTM) with
STEEN SolutionTM
Perfusate.
H130004, FDA-2014-M-1280........... Plexision, Inc....... PleximmuneTM......... August 26, 2014.
P130020, FDA-2014-M-1279........... GE Healthcare........ SenoClaire........... August 26, 2014.
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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: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02783 Filed 2-10-15; 8:45 am]
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