[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
