[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Notices]
[Pages 60704-60705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24479]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-M-0371, FDA-2012-M-0372, FDA-2012-M-0373, FDA-
2012-M-0390, FDA-2012-M-0407, FDA-2012-M-0562, and FDA-2012-M-0638]
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
[[Page 60705]]
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 April 1, 2012, through June 30, 2012.
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 April 1, 2012, Through
June 30, 2012
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PMA No., Docket No. Applicant Trade name Approval date
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P020018/S040, FDA-2012-M-0371..... Cook, Inc............ Zenith[supreg] Fenestrated April 4, 2012.
AAA Endovascular Graft
(with the adjunctive
Zenith Alignment Stent).
P110029, FDA-2012-M-0372.......... Abbot Laboratories... ARCHITECT HBsAg April 12, 2012.
Qualitative, ARCHITECT
HBsAg Qualitative
Confirmatory, ARCHITECT
HBsAg Qualitative
Confirmatory Manual
Diluent, ARCHITECT HBsAg
Qualitative Calibrators,
and ARCHITECT HBsAg
Qualitative Controls.
P110004, FDA-2012-M-0407.......... Medinol Ltd.......... Presillion\TM\ plus CoCr April 12, 2012.
Coronary Stent on RX
System.
P110035, FDA-2012-M-0373.......... Boston Scientific Epic\TM\ Vascular Self- April 13, 2012.
Corp. Expanding Stent System.
P090015, FDA-2012-M-0390.......... Leica Biosystems..... BOND\TM\ ORACLE\TM\ HER2 April 18, 2012.
IHC System.
P110010/S001, FDA-2012-M-0562..... Boston Scientific PROMUS[supreg] Element\TM\ June 1, 2012.
Corp. Plus Everolimus-Eluting
Platinum Chromium
Coronary Stent System
(Monorail\TM\ and Over-
the-Wire).
P090026, FDA-2012-M-0638.......... Beckman Coulter, Inc. Access[supreg] June 14, 2012.
Hybritech[supreg] p2PSA
on the Access Immunoassay
Systems.
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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: September 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24479 Filed 10-3-12; 8:45 am]
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