[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Notices]
[Pages 55153-55154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0371]


Guidant Corp.; Premarket Approval of SELUTE Steroid 
Eluting Endocardial Lead Models 4185 and 4285

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Guidant Corp., St. Paul, MN, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of SELUTE Steroid Eluting Endocardial Lead Models 4185 
and 4285. FDA's Center for Devices and Radiological Health (CDRH) 
notified the applicant, by letter of May 8, 1996, of the approval of 
the application.

DATES: Petitions for administrative review by November 25, 1996.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Lynette A. Gabriel, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8243.

SUPPLEMENTARY INFORMATION: On January 13, 1995, Guidant Corp., St. 
Paul, MN 55112-5798, submitted to CDRH an application for premarket 
approval of SELUTE Steroid Eluting Endocardial Lead Models 
4185 and 4285. The device is a permanent pacing lead and is indicated 
for chronic pacing and sensing of the ventricle when used with a 
compatible pulse generator.
    In accordance with the provisions of section 515(c)(2) of the act 
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 
1990, this premarket approval application (PMA) was not referred to the 
Circulatory System Devices Panel of the Medical Devices Advisory 
Committee, an FDA advisory committee, for review and recommendation 
because the information in the PMA substantially duplicates information 
previously reviewed by this panel.
    On May 8, 1996, CDRH approved the application by a letter to the 
applicant from the Director of the Office of Device Evaluation, CDRH. 
In that letter, CDRH also notified the applicant that the device 
requires tracking under section 519(e) of the act (21 U.S.C. 360i(e)).
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act authorizes any interested person to 
petition, under section 515(g) of the act, for administrative review of 
CDRH's decision to approve this application. A petitioner may request 
either a formal hearing under part 12 (21 CFR part 12) of FDA's 
administrative practices and procedures regulations or a review of the 
application and CDRH's action by an independent advisory committee of 
experts. A petition is to be in the form of a petition for 
reconsideration under Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner 
shall identify the form of review requested (hearing or independent 
advisory committee) and shall submit with the petition supporting data 
and information showing that there is a genuine and substantial issue 
of material fact for resolution through administrative review. After 
reviewing the petition, FDA will decide whether to grant or deny the 
petition and will publish a notice of its decision in the Federal 
Register. If FDA grants the petition, the

[[Page 55154]]

notice will state the issue to be reviewed, the form of review to be 
used, the persons who may participate in the review, the time and place 
where the review will occur, and other details.
    Petitioners may, at any time on or before November 25, 1996, file 
with the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: September 20, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-27202 Filed 10-23-96; 8:45 am]
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