[Federal Register: September 13, 2007 (Volume 72, Number 177)]
[Notices]
[Page 52380-52382]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se07-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M-0174, 2007M-0259, 2007M-0161, 2007M-0160, 2007M-
0151, 2007M-0152, 2007M-0153, 2007M-0188, 2007M-0156, 2007M-0154,
2007M-0180, 2007M-0189, 2007M-0190, 2007M-0253, 2007M-0255, 2007M-0254]
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: Samie Allen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4013.
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
[[Page 52381]]
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, 2007, through June 30, 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 April 1, 2007, through June 30, 2007.
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PMA No./ Approval
Docket No. Applicant TRADE NAME Date
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P050049/2007M- Abbott ABBOTT AXSYM HBSAG ASSAY June 1,
0174 Laboratories 2006
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P040048/2007M- Zimmer, Inc. TRILOGY AB ACETBULAR June 28,
0259 SYSTEM 2006
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P060003/2007M- Abbott AXSYM AUSAB REAGENT PACK, August 7,
0161 Laboratories STANDARD CALIBRATORS, 2006
CONTROLS
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P060009/2007M- Abbott AXSYM CORE-M 2.0 & 2.0 August 25,
0160 Laboratories CONTROLS 2006
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P050048/2007M- Bio-Rad MONOLISA ANTI-HBS EIA August 25,
0151 Laboratories, 2006
Inc.
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P060007/2007M- Abbott ARCHITECT HBSAG REAGENT September
0152 Laboratories KIT, CALIBRATORS, 7, 2006
CONTROLS, CONFIRMATORY
REAGENT KIT, CONFIRMATORY
MANUAL DILUENT
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P060012/2007M- Abbott AXSYM CORE 2.0 & AXSYM September
0153 Laboratories CORE 2.0 CONTROLS 8, 2006
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P990037(S24)/ Vascular VASCULAR SOLUTIONS D-STAT December
2007M-0188 Solutions, Inc. FLOWABLE HEMOSTAT 22, 2006
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H060003/2007M- EV3 Neurovascular ONYX LIQUID EMBOLIC SYSTEM April 11,
0156 (ONYX HD-500, MODEL 105- 2007
8101-500)
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P050046/2007M- Guidant Corp. ACUITY STEERABLE LEAD April 13,
0154 MODELS 4554, 4555, & 4556 2007
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P040024(S006)/ Medicis PERLANE INJECTABLE GEL May 2,
2007M-0180 Aesthetics 2007
Holdings, Inc.
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P060011/2007M- Rayner Surgical, C-FLEX MODEL 570C May 3,
0189 Inc. INTRAOCULAR LENS (IOL) 2007
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H060001/2007M- Cordis ENTERPRISE VASCULAR May 8,
0190 Neurovascular, RECONSTRUCTION DEVICE AND 2007
Inc. DELIVERY SYSTEM
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P050004/2007M- Electro Medical EMS SWISS DOLORCLAST May 8,
0253 Systems (EMS) 2007
S.A.
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P050012(S001)/ Dexcom, Inc. STS-7 CONTINUOUS GLUCOSE May 31,
2007M-0255 MONITORING SYSTEM 2007
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P060034/2007M- Bio-Rad BIO RAD MONOLISA ANTI-HBC May 31,
0254 Laboratories IGM EIA 2007
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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: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-18034 Filed 9-12-07; 8:45 am]
BILLING CODE 4160-01-S