[Federal Register Volume 60, Number 139 (Thursday, July 20, 1995)]
[Notices]
[Pages 37454-37455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17832]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0180]
Chiron Vision Corp.; Premarket Approval of Adatomed Silicone Oil
OP5000
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 Chiron Vision Corp., Irvine, CA, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of Adatomed Silicone Oil OP5000. After reviewing the
recommendation of the Opthalmic Devices Panel, FDA's Center for Devices
and Radiological Health (CDRH) notified the applicant, by letter of
November 4, 1994, of the approval of the application.
DATES: Petitions for administrative review by August 21, 1995.
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, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Debra Y. Lewis, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2018.
SUPPLEMENTARY INFORMATION: On March 5, 1992, Chiron Vision Corp.,
Irvine, CA 92718-1903, submitted to CDRH an application for premarket
approval of Adatomed Silicone Oil OP5000. The device is an intraocular
fluid and is indicated for use as a prolonged retinal tamponade in
selected cases of complicated retinal detachments.
On October 28, 1993, the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application.
On November 4, 1994, 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 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
[[Page 37455]]
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 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 August 21, 1995, 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: July 5, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-17832 Filed 7-19-95; 8:45 am]
BILLING CODE 4160-01-F
