Medical Devices; Availability of Safety and Effectiveness Summaries for PMA

[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Notices]
[Pages 68694-68695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31697]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 99M-1521, 99M-1980, 99M-1696, 99M-1981, 99M-2028, 99M-
1520, 99M-1982, 99M-0150, 99M-0255, 99M-2016, 99M-2015, 99M-0871, 99M-
0870, 99M-1851]

Medical Devices; Availability of Safety and Effectiveness
Summaries for PMA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket application (PMA) approvals. This list is intended to inform
the public of the availability of safety and effectiveness summaries of
approved PMA's through the Internet and the agency's Dockets Management
Branch.

ADDRESSES: Summaries of safety and effectiveness are available on the
Internet at https://www.fda.gov/cdrh/pmapage.html. Copies of summaries
of safety and effectiveness are also available by submitting a written
request to the Dockets Management Branch (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 in the
Supplementary Information section of this document when submitting a
written request.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 30, 1998
(63 FR 4571), FDA published a final rule to revise Secs. 814.44(d) and
814.45(d) (21 CFR 814.44(d) and 814.45(d)) to discontinue publication
of individual PMA approvals and denials in the Federal Register.
Revised Secs. 814.44(d) and 814.45(d) state that FDA will notify the
public of PMA approvals and denials by posting them on FDA's home page
on the Internet at https://www.fda.gov; by placing the summaries of
safety and effectiveness on the Internet and in FDA's Dockets
Management Branch; and by publishing in the Federal Register after each
quarter a list of available safety and effectiveness summaries of
approved PMA's and denials announced in that quarter.
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)(3) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)), 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 following is a list of approved PMA's for which summaries of
safety and effectiveness were placed on the Internet in accordance with
the procedure explained previously from April 1, 1999, through June 30,
1999. There were no denial actions during this period. The list
provides the manufacturer's name, the generic name or the trade name,
and the approval date.

[[Page 68695]]

Table 1.--List of Safety and Effectiveness Summaries for Approved PMA's Made Available April 1, 1999, through June 30, 1999
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Number/Docket No. Applicant Trade Name Approval Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
P870072(S5)/99M-1521 Thoratec Laboratories Corp. Thoratec May 21, 1998
Ventricular Assist Device
P970061/99M-1980 Boston Scientific-SCIMED SCIMED Radius Coronary Stent July 16, 1998
with Delivery System
P980001/99M-1696 Boston Scientific Corp. NIR ON^TM Ranger^TM Premounted August 11, 1998
Stent System
P970024/99M-1981 Angeion Corp. Defibrillator (ICD) System August 19, 1998
and the Angeflex^TM
Defibrillation Lead System
P980009/99M-2028 Boston Scientific Corp. Magic Wallstent Endoprothesis September 29, 1998
P920014(S7)/99M-1520 Thermo Cardiosystems, Inc. Heartmate VE LVAS September 29, 1998
P960006/99M-1982 Guidant Corp. Sweet Tip Rx October 2, 1998
Steroid Eluting Lead
H980005/99M-0150 NeuroControl Corp. VOCARE Bladder December 28, 1998
System
H980008/99M-0255 NeuroControl Corp. VOCARE Bladder February 19, 1999
System
P980003/99M-2016 Cardiac Pathways Corp. Chilli Cooled RF February 2, 1999
Ablation System
P980037/99M-2015 Possis Medical, Inc. Angiojet Rheolytic March 12, 1999
Thrombectomy LF140
P850020(S11)/99M-0871 Cypress Bioscience, Inc. Prosorba^TM Column March 15, 1999
P920023(S7)/99M-0870 American Medical Systems, Urolume Endoprosthesis March 29, 1999
Inc.
P960016/99M-1851 Daig Corp. Radio Frequency-Powered May 4, 1999
Cardiac Catheter Ablation
System
--------------------------------------------------------------------------------------------------------------------------------------------------------

Dated: November 24, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-31697 Filed 12-7-99; 8:45 am]
BILLING CODE 4160-01-F

Medical Devices; Availability of Safety and Effectiveness Summaries for PMA

Federal Register Citation

Suggested Web Citation