[Federal Register: June 7, 2007 (Volume 72, Number 109)]
[Notices]
[Page 31586-31587]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn07-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M-0109, 2007M-0006, 2007M-0007, 2007M-0032, 2007M-
0049, 2007M-0038, 2007M-0058, 2007M-0086, 2007M-0107, 2007M-0084,
2007M-0108]
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: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4010, ext. 152.
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
[[Page 31587]]
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 January 1, 2007, through March 31,
2007. 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, 2007, through March 31, 2007
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PMA No./Docket Approval
No. Applicant Trade Name Date
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P040051/2007M- Stelkast Co. STELKAST SURPASS May 12, 2006
0109 ACETABULAR SYSTEM
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P050037/2007M- Bioform RADIESSE 1.3 CC AND 0.3 December 22,
0006 Medical, Inc. CC 2006
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P050052/2007M- Bioform RADIESSE 1.3 CC AND 0.3 December 22,
0007 Medical, Inc. CC 2006
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P050018/2007M- Angioscore, ANGIOSCULPT SCORING January 8,
0032 Inc. BALLOON CATHETER 2007
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P060001/2007M- EV3, Inc. PROTEGE GPS AND PROTEGE January 24,
0049 RX CAROTID STENT SYSTEMS 2007
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H060004/2007M- Fujirebio FUJIREBIO MESOMARK ASSAY January 24,
0038 Diagnostics, 2007
Inc.
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P050007(S1)/ Abbott STARCLOSE VASCULAR February 2,
2007M-0058 Vascular CLOSURE SYSTEM 2007
Devices
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P050013/2007M- Tissue Seal, HISTOACRYL & HISTOACRYL February 16,
0086 LLC. BLUE TOPICAL SKIN 2007
ADHESIVE
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P980022(S15)/ Medtronic GUARDIAN RT & PARADIGM March 8,
2007M-0107 Minimed REAL-TIME CONTIUOUS 2007
GLUCOSE MONITORING
SYSTEMS
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P050053/2007M- Medtronic INFUSE BONE GRAFT March 9,
0084 Sofamor Danek 2007
USA, Inc.
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P060019/2007M- Irvine IBI THERAPY COOL PATH March 16,
0108 Biomedical, ABLATION CATHETER & IBI- 2007
Inc. 1500T9 RF ABLATION
GENERATOR
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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: May 24, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-11002 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S