[Federal Register: September 6, 2005 (Volume 70, Number 171)]
[Notices]
[Page 53019-53021]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se05-64]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005M-0158, 2005M-0159, 2005M-0129, 2005M-0160, 2005M-
0130, 2005M-0151, 2005M-0117, 2005M-0118, 2005M-0241, 2005M-0191,
2005M-0192, 2005M-0193, 2005M-0270]
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
[[Page 53020]]
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 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.
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, 2005, through June 30, 2005.
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, 2005,
through June 30, 2005.
----------------------------------------------------------------------------------------------------------------
PMA No./Docket No. Applicant TRADE NAME Approval Date
----------------------------------------------------------------------------------------------------------------
P030040/2005M-0158 Bayer Healthcare, LLC ADVIA CENTAUR HBC IGM READY PACK REAGENTS, August 6, 2004
ADVIA CENTAUR HBC IGM QUALITY CONTROL
MATERIAL
----------------------------------------------------------------------------------------------------------------
P020055/2005M-0159 Ventana Medical VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT August 11, 2004
Systems, Inc. (9.7)
PRIMARY ANTIBODY
----------------------------------------------------------------------------------------------------------------
P040018/2005M-0129 Bayer Healthcare, LLC ADVIA CENTAUR HAV IGM READY PACK REAGENTS, December 22, 2004
ADVIA CENTAUR HAV IGM QUALITY CONTROL
MATERIAL
----------------------------------------------------------------------------------------------------------------
P040030/2005M-0160 BioGenex INSITE HER-2/NEU KIT December 22, 2004
Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
P030052/2005M-0130 Vysis, Inc. UROVYSION BLADDER CANCER KIT January 24, 2005
----------------------------------------------------------------------------------------------------------------
P930016(S20)/2005M-0151 VISX, Inc. STAR S4 IR EXCIMER LASER SYSTEM WITH March 17, 2005
VARIABLE
SPOT SCANNING (VSS)
----------------------------------------------------------------------------------------------------------------
P040020/2005M-0117 Alcon Research, Ltd. ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC March 21, 2005
POSTERIOR CHAMBER IOL
----------------------------------------------------------------------------------------------------------------
P040024/2005M-0118 Medicis Aesthetics RESTYLANE INJECTABLE GEL March 25, 2005
Holdings, Inc.
----------------------------------------------------------------------------------------------------------------
P040026/2005M-0241 Medispec, Ltd. ORTHOSPEC EXTRACORPOREAL SHOCK WAVE April 1, 2005
THERAPY DEVICE
----------------------------------------------------------------------------------------------------------------
P040034/2005M-0191 Confluent Surgical, DURASEAL DURAL SEALANT SYSTEM April 7, 2005
Inc.
----------------------------------------------------------------------------------------------------------------
P040016/2005M-0192 Boston Scientific BOSTON SCIENTIFIC CORPORATION LIBERTE April 12, 2005
Corp. MONORAIL
AND OVER-THE-WIRE CORONARY STENT SYSTEMS
----------------------------------------------------------------------------------------------------------------
P030037/2005M-0193 Biotronik, Inc. RITHRON-XR CORONARY STENT SYSTEM April 29, 2005
----------------------------------------------------------------------------------------------------------------
P030049/2005M-0270 Bayer Healthcare, LLC ADVIA CENTAUR HBS AG READY PACK REAGENTS, May 31, 2005
ADVIA CENTAUR HBS AG CONFIRMATORY READY
PACK REAGENTS, AND ADVIA CENTAUR HBS AG
QUALITY CONTROL MATERIAL
----------------------------------------------------------------------------------------------------------------
[[Page 53021]]
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 22, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-17602 Filed 9-2-05; 8:45 am]
BILLING CODE 4160-01-S