[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