[Federal Register Volume 62, Number 73 (Wednesday, April 16, 1997)]
[Notices]
[Page 18638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0139]


Genzyme Corp.; Premarket Approval of SeprafilmTM 
Bioresorbable Membrane

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 Genzyme Corp., Cambridge, MA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of SeprafilmTM Bioresorbable Membrane. After reviewing the 
recommendation of the General and Plastic Surgery Devices Panel, FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of August 12, 1996, of the approval of the 
application.

DATES: Petitions for administrative review by May 16, 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: Stephen P. Rhodes, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION: On October 27, 1995, Genzyme Corp., 
Cambridge, MA 02139-1562, submitted to CDRH an application for 
premarket approval of SeprafilmTM Bioresorbable Membrane. The 
device is an absorbable adhesion barrier and is indicated for use in 
patients undergoing abdominal or pelvic laparotomy as an adjunct 
intended to reduce the incidence, extent, and severity of postoperative 
adhesions between the abdominal wall and the underlying viscera such as 
omentum, small bowel, bladder, and stomach, and between the uterus and 
surrounding structures such as tubes and ovaries, large bowel and 
bladder.
    On March 25, 1996, the General and Plastic Surgery Devices Panel of 
the Medical Devices Advisory Committee, an FDA advisory committee, 
reviewed and recommended approval of the application. On August 12, 
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 May 15, 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 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: March 17, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-9726 Filed 4-15-97; 8:45 am]
BILLING CODE 4160-01-F