[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]
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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.
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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