[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37066-37067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17971]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0259]
Kensey Nash Corp.; Premarket Approval of the Angio-
SealTM Hemostatic Puncture Closure Device
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 Kensey Nash Corp., Exton, PA, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the Angio-SealTM Hemostatic Puncture Closure
Device. After reviewing the recommendation of the Circulatory System
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH)
notified the applicant, by letter of September 30, 1996, of the
approval of the application.
DATES: Petitions for administrative review by August 11, 1997.
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: Christopher M. Sloan, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8243.
SUPPLEMENTARY INFORMATION: On October 28, 1993, Kensey Nash Corp.,
Exton, PA 19341, submitted to CDRH an application for premarket
approval of the Angio-SealTM Hemostatic Puncture Closure
Device. The device is a vascular hemostasis device and is indicated for
use in closing and in reducing time to hemostasis at the femoral
arterial puncture site in patients who have undergone diagnostic
angiography or percutaneous transluminal coronary angioplasty (PTCA)
procedures using an 8F or smaller procedure sheath.
On May 8, 1995, the Circulatory System Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On September 30, 1996, CDRH
approved the application by a letter to the applicant from the Director
of the Office of Device Evaluation, CDRH.
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 (21 U.S.C. 360e(d)(3)) 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 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 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 notice will state the issue to be reviewed,
the form of the 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 August 11, 1997 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
[[Page 37067]]
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: June 10, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-17971 Filed 7-9-97; 8:45 am]
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