[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]


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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.

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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 http://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 http://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
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                   PMA Number/Docket No.                               Applicant                      Trade Name                   Approval Date
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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 ONTM RangerTM Premounted   August 11, 1998
                                                                                             Stent System
P970024/99M-1981                                             Angeion Corp.                  Defibrillator (ICD) System     August 19, 1998
                                                                                             and the AngeflexTM
                                                                                             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.       ProsorbaTM 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
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    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