[Federal Register Volume 60, Number 241 (Friday, December 15, 1995)]
[Notices]
[Pages 64438-64439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30610]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95M-0394]
Datascope Corp.; Premarket Approval of the VasoSeal Vascular
Hemostasis 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 Datascope Corp., Montvale, NJ, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the VasoSeal Vascular Hemostasis Device (VHD). FDA's Center
for Devices and Radiological Health (CDRH) notified the applicant, by
letter of
[[Page 64439]]
September 29, 1995, of the approval of the application.
DATES: Petitions for administrative review by January 16, 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: 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 February 3, 1992, Datascope Corp.,
Montvale, NJ 07645, submitted to CDRH an application for premarket
approval of the VasoSeal Vascular Hemostasis Device. The device is a
vascular hemostasis device and is indicated for use 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 8 French or smaller procedural
sheath. The VasoSeal VHD is also indicated for use in PTCA patients
when immediate sheath removal is desired.
-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 29, 1995, 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 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
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 January 16, 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: November 29, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-30610 Filed 12-14-95; 8:45 am]
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