[Federal Register: September 26, 2006 (Volume 71, Number 186)]
[Notices]
[Page 56157-56158]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se06-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M-0161, 2006M-0264, 2006M-0148, 2006M-0200, 2006M-
0162, 2006M-0199, 2006M-0193, 2006M-0235]
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
[[Page 56158]]
(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 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, 301-594-2186, 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 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, 2006, through June 30, 2006.
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, 2006, through June 30, 2006
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PMA No./Docket Approval
No. Applicant Trade Name Date
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P050021/2006M- QLT, Inc. CERALAS I LASER & CERALINK December
0161 SLIT LAMP ADAPTER 20, 2005
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P040052/2006M- MonoGen, Inc. MONOPREP PAP TEST (MPPT) March 3,
0264 2006
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P040028/2006M- Medispectra, LUMA CERVICAL IMAGING March 16,
0148 Inc. SYSTEM 2006
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P050012/2006M- Dexcom, Inc. DEXCOM (STS) CONTINUOUS March 24,
0200 GLUCOSE MONITORING SYSTEM 2006
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P050026/2006M- QLT, Inc. QUALTEL ACTIVIS LASER & April 4,
0162 ZSL30 ACT, ZSL120 ACT, 2006
and HSBMBQ ACT SLIT LAMP
ADAPTERS
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P030008(S4)/ SurgiVision WAVELIGHT ALLEGRETTO WAVE April 19,
2006M-0199 Refractive EXCIMER LASER SYSTEM 2006
Consultants
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P040033/2006M- Smith & Nephew BIRMINGHAM HIP RESURFACING May 9, 2006
0193 Orthopaedics (BHR) SYSTEM
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P050047/2006M- Inamed Corp. JUVEDERM 24HV, JUVEDERM June 2,
0235 30, and JUVEDERM 30HV GEL 2006
IMPLANTS
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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: September 15, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-15755 Filed 9-25-06; 8:45 am]
BILLING CODE 4160-01-S