[Federal Register Volume 60, Number 243 (Tuesday, December 19, 1995)]
[Notices]
[Pages 65347-65348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30697]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0393]


Bioetica, Inc.; Premarket Approval of HEMOSTAGENE<Register> 
Absorbable Collagen Hemostatic Sponge

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 Bioetica, Inc., Westbrook, ME, on behalf 
of Coletica, S. A., Lyon, France, for premarket approval, under the 
Federal Food, Drug, and Cosmetic Act (the act), of 
HEMOSTAGENE<Register> Absorbable Collagen Hemostatic Sponge. FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of August 15, 1995, of the approval of the 
application.

DATES: Petitions for administrative review by January 18, 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: Frances M. Curtis, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION: On August 30, 1993, the U.S. representative, 
Bioetica, Inc., Westbrook, ME 04092, on behalf of Coletica, S. A., 
Lyon, France, submitted to CDRH an application for premarket approval 
of HEMOSTAGENE<Register> Absorbable Collagen Hemostatic Sponge. The 
device is an absorbable hemostatic agent and is indicated for use in 
surgical procedures (other than in neurosurgical, ophthalmic, and 
urological) as an adjunct to hemostasis when control of bleeding by 
ligature or conventional procedures is ineffective or impractical.
    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 
General and Plastic Surgery Devices Panel of the 

[[Page 65348]]
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 August 15, 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 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 18, 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. 95-30697 Filed 12-18-95; 8:45 am]
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