[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Notices]
[Page 30950-30951]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my08-74]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-M-0467] (formerly Docket No. 2007M-0408), [Docket
No. FDA-2007-M-0481] (formerly Docket No. 2007M-0467), [Docket No. FDA-
2007-M-0480] (formerly Docket No. 2007M-0409), [Docket No. FDA-2007-M-
0472] (formerly Docket No. 2007M-0413), [Docket No. FDA-2007-M-0468]
(formerly Docket No. 2007M-0446), [Docket No. FDA-2007-M-0494]
(formerly Docket No. 2007M-0380), [Docket No. FDA-2007-M-0493]
(formerly Docket No. 2007M-0411), [Docket No. FDA-2007-M-0492]
(formerly Docket No. 2007M-0410), [Docket No. FDA-2007-M-0490]
(formerly Docket No. 2007M-0415), [Docket No. FDA-2007-M-0491]
(formerly Docket No. 2007M-0447]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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:
[[Page 30951]]
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, 2007, through December 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 October 1, 2007, through December 31, 2007.
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant TRADE NAME Date
------------------------------------------------------------------------
P000009 (S4)/ Biotronik, TACHOS DR ATRIAL TX September
2007M-0408 Inc. IMPLANTABLE CARDIOVERTER 9, 2002
DEFIBRILLATOR ICD SYSTEM
------------------------------------------------------------------------
P060031/2007M- Bio-Rad BIO-RAD MONOLISA ANTI-HBC April 27,
0467 Laboratories EIA 2007
------------------------------------------------------------------------
P060005/2007M- Siemens IMMULITE/IMMULITE 1000 & May 11,
0409 Medical IMMULITE 2000 FREE PSA 2007
Solutions ASSAYS
Diagnostics
------------------------------------------------------------------------
P060017/2007M- Veridex, LLC GENESEARCH BREAST LYMPH July 16,
0413 NODE (BLN) ASSAY 2007
------------------------------------------------------------------------
P040040/2007M- AGA Medical AMPLATZER MUSCULAR VSD September
0446 Corp. 7, 2007
------------------------------------------------------------------------
P070009/2007M- Obtech Medical REALIZE ADJUSTABLE GASTRIC September
0380 GMBH BAND MODEL 2200-X 28, 2007
------------------------------------------------------------------------
P070012/2007M- Medtronic EXPONENT SELF-EXPANDING October 23,
0411 Vascular CAROTIC STENT SYSTEM WITH 2007
OVER THE WIRE OR RAPID
EXHANGE DELIVERY SYSTEM
------------------------------------------------------------------------
P060038/2007M- Carbomedics, MITROFLOW AORTIC October 23,
0410 Inc. PERICARDIAL HEART VALVE 2007
------------------------------------------------------------------------
H990002/2007M- Genzyme EPICEL (CULTURED EPIDERMAL October 25,
0415 Biosurgery AUTOGRAFTS) 2007
------------------------------------------------------------------------
P060035/2007M- Abbott ARCHITECT CORE-M REAGENT November 6,
0447 Laboratories KIT/CALIBRATORS/CONTROLS 2007
------------------------------------------------------------------------
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 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12012 Filed 5-28-08; 8:45 am]
BILLING CODE 4160-01-S