[Federal Register: March 19, 2009 (Volume 74, Number 52)]
[Notices]
[Page 11734-11735]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr09-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-M-0535, FDA-2008-M-0547, FDA-2008-M-0536, FDA-
2008-M-0563, FDA-2008-M-0593, FDA-2008-M-0601, FDA-2008-M-0562, FDA-
2008-M-0596, FDA-2008-M-0579, FDA-2008-M-0594, FDA-2008-M-0608, FDA-
2008-M-0645, FDA-2008-M-0646]
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 (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4010.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the 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 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 October 1, 2008, through December 31,
2008. 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.
[[Page 11735]]
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From October 1, 2008, through December 31, 2008.
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PMA No./Docket Approval
No. Applicant TRADE NAME Date
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P070015 Abbott XIENCE V EVEROLIMUS ELUTING July 2,
FDA-2008-M-053 Vascular Inc. CORONARY STENT SYSTEM & 2008
5 PROMUS ELUTING CORONARY
STENT SYSTEM
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P030025 (S28) Boston TAXUS EXPRESS2 PACLITAXEL September
FDA-2008-M-054 Scientific ELUTING CORONARY STENT 24, 2008
7 Corp. SYSTEM
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P080004 Hoya Surgical HOYA ISPHERIC MODEL YA-60BB September
FDA-2008-M-053 Optics, Inc. INTRAOCULAR LENS 26, 2008
6
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H070004 Levitronix, LEVITRONIX CENTRIMAG RIGHT October 7,
FDA-2008-M-056 LLC VENTRICULAR ASSIST SYSTEM 2008
3 (RVAS)
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P060008 Boston TAXUS LIBERTE' PACLITAXEL October 10,
FDA-2008-M-059 Scientific ELUTING CORONARY STENT 2008
3 Corp. SYSTEM
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P050029 Stereotaxis, HELIOS II ABLATION CATHETER October 10,
FDA-2008-M-060 Inc. 2008
1
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H040004 Medtronic INFUSE/MASTERGRAFT October 10,
FDA-2008-M-056 Sofamor Danek POSTEROLATERAL REVISION 2008
2 USA, Inc. DEVICE
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P050019 Boston CAROTID WALLSTENT MONORAIL October 23,
FDA-2008-M-059 Scientific ENDOPROSTHESIS 2008
6 Corp.
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H060002 Spiration, IBV VALVE SYSTEM October 24,
FDA-2008-M-057 Inc. 2008
9
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P060025 ATS Medical, ATS 3F AORTIC BIOPROSTHESIS October 30,
FDA-2008-M-059 Inc. 2008
4
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P080011 Coopervision BIOFINITY COMFILCON A November
FDA-2008-M-060 Manufacturing (EXTENDED WEAR SOFT 19, 2008
8 , Ltd. CONTACT LENSES)
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P080007 Bard BARD E-LUMINEXX VASCULAR December 4,
FDA-2008-M-064 Peripheral STENT 2008
5 Vascular Inc.
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P060006 Boston BOSTON SCIENTIFIC EXPRESS December
FDA-2008-M-064 Scientific SD RENAL MONORAIL 11, 2008
6 Corp. PREMOUNTED STENT SYSTEM
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/pmapage.html.
Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-6026 Filed 3-18-09; 8:45 am]
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