[Federal Register Volume 59, Number 136 (Monday, July 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17374]


[[Page Unknown]]

[Federal Register: July 18, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0213]

 

Allergan Medical Optics; Premarket Approval of the Model PC-28LB 
Ultraviolet-Absorbing Posterior Chamber Intraocular Lens

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Allergan Medical Optics, Irvine, CA, for 
premarket approval, under section 515 of the Federal Food, Drug, and 
Cosmetic Act (the act), of the Model PC-28LB ultraviolet-absorbing 
posterior chamber intraocular lens. After reviewing the recommendation 
of the Ophthalmic Devices Panel, FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter of May 26, 
1994, of the approval of the application.

DATES: Petitions for administrative review by August 17, 1994.

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: Donna L. Rogers, Center for Devices 
and Radiological Health (HFZ-463), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-2053.

SUPPLEMENTARY INFORMATION: On February 8, 1990, Allergan Medical 
Optics, Irvine, CA 92718, submitted to CDRH an application for 
premarket approval of the Model PC-28LB ultraviolet-absorbing posterior 
chamber intraocular lens. This device is indicated for primary 
implantation for the visual correction of aphakia in persons 60 years 
of age or older where a cataractous lens has been removed by 
extracapsular cataract extraction methods. The lens is intended to be 
placed in either the ciliary sulcus or capsular bag.
    On April 19, 1990, the Ophthalmic Devices Panel, an FDA advisory 
panel, reviewed and recommended approval of the application. On May 26, 
1994, CDRH approved the application by a letter to the applicant from 
the Acting 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 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 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 17, 1994, 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 Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: July 1, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-17374 Filed 7-15-94; 8:45 am]
BILLING CODE 4160-01-F