[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]
BILLING CODE 4160-01-F
