[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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