[Federal Register Volume 73, Number 188 (Friday, September 26, 2008)]
[Notices]
[Pages 55852-55853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22668]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-M-0207, FDA-2008-M-0243, FDA-2008-M-0244, FDA-
2008-M-0283, FDA-2008-M-0335, FDA-2008-M-0311, FDA-2008-M-0342, FDA-
2008-M-0378]
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://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 55853]]
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 April 1, 2008, through June 30, 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.
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From April 1, 2008, through June 30, 2008
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PMA No./ Approval
Docket No. Applicant TRADE NAME Date
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P050020 Abbott Diabetes FREESTYLE NAVIGATOR March 12,
FDA-2008-M-02 Care, Inc. CONTINUOUS GLUCOSE 2008
07 MONITORING SYSTEM
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P010012 Guidant Corp. Contak Renewal 3 AVT March 13,
(S037) system & contak reviewal 2008
FDA-2008-M-02 3AVT HE System
43
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P070027 Medtronic The talent abdominal stent April 15,
FDA-2008-M-02 Vascular graft system 2008
44
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P060040 Thoratec Corp. Thoratec Heartmate II Left April 21,
FDA-2008-M-02 ventricular assist 2008
83
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P070008 Biotronik, Inc. Stratos LV CRT-P & stratos May 12,
FDA-2008-M-03 LV-T CRT-P, corox OTW BP 2008
35 lead & corox OTW-s bp
lead
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P070016 Cook, Inc. Zenith TX2 Thoracic TAA May 21,
FDA-2008-M-03 endovascular graft with 2008
11 the H&LB One-shot
introduction system
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P070007 Medtronic Talent Thoracic Stent June 5,
FDA-2008-M-03 Vascular Graft System 2008
42
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H070003 Synapse NeuRx RA/4 June 17,
FDA-2008-M-03 Biomedical, Inc. 2008
78
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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: September 12, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-22668 Filed 9-25-08; 8:45 am]
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