[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Notices]
[Pages 31965-31966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13692]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-M-0034, FDA-2011-M-0040, FDA-2011-M-0041, FDA-
2011-M-0039, FDA-2011-M-0035, FDA-2011-M-0056, FDA-2011-M-0105, FDA-
2011-M-0131, FDA-2011-M-0132, FDA-2011-M-0170, FDA-2011-M-0175, and
FDA-2011-M-0198]
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 of this document 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 the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that amended 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the Agency now posts this information on the
Internet on FDA's home page at http://www.fda.gov.
In accordance with section 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, 2011, through March 31,
2011. 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, 2011,
Through March 31, 2011
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PMA No. Docket No. Applicant Trade name Approval date
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P010012 (S230)................... Boston Scientific BOSTON SCIENTIFIC September 16, 2010.
Corp. CARDIAC
RESYNCHRONIZATION
THERAPY DEFIBRILLATORS.
FDA-2011-M-0034
P100021.......................... Medtronic Vascular. MEDTRONIC VASCULAR December 16, 2010.
ENDURANT STENT GRAFT
SYSTEM.
FDA-2011-M-0040
P100010.......................... Medtronic Cryocath, ARCTIC FRONT December 17, 2010.
LP. CRYOCATHETER SYSTEM.
FDA-2011-M-0041
P070014 (S10).................... Bard Peripheral LIFESTENT AND LIFESTENT December 23, 2010.
Vascular. LX VASCULAR STENT
SYSTEMS.
FDA-2011-M-0039
P070026.......................... Depuy, Inc......... CERAMAX CERAMIC HIP December 23, 2010.
SYSTEM.
FDA-2011-M-0035
P100028.......................... Cook Medical, Inc.. FORMULA BALLOON- January 14, 2011.
EXPANDABLE RENAL STENT
SYSTEM.
FDA-2011-M-0056
P090013.......................... Medtronic, Inc..... REVO MRI SURESCAN IPG February 8, 2011.
AND PACING SYSTEM.
FDA-2011-M-0105
P080003.......................... Hologic, Inc....... SELENIA DIMENSIONS 3D February 11, 2011.
SYSTEMS.
FDA2011-M-0131
P080027 (S1)..................... OraSure ORAQUICK HCV RAPID February 18, 2011.
Technologies, Inc. ANTIBODY TEST.
FDA-2011-M-0132
H080005.......................... Elana, Inc......... ELANA SURGICAL KIT HUD.. March 10, 2011.
FDA-2011-M-0170
P080025.......................... Medtronic MEDTRONIC INTERSTIM March 14, 2011.
Neuromodulation. THERAPY SYSTEM.
FDA-2011-M-0175
[[Page 31966]]
P80020........................... Seikagaku Corp..... GEL-ONE................. March 22, 2011.
FDA-2011-M-0198
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.
Dated: May 27, 2011.
Nancy K. Stade,
Deputy Director for Policy Center for Devices and Radiological Health.
[FR Doc. 2011-13692 Filed 6-1-11; 8:45 am]
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