[Federal Register Volume 61, Number 136 (Monday, July 15, 1996)]
[Notices]
[Pages 36887-36888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17825]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0221]
Alcon Laboratories, Inc.; Premarket Approval of Acrysof
Models MA60BM and MA30BA Ultraviolet-Absorbing Soft Acrylic Posterior
Chamber Intraocular Lenses
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 Alcon Laboratories, Inc., Fort Worth,
TX, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of Acrysof Models MA60BM and MA30BA
ultraviolet-absorbing soft acrylic posterior chamber intraocular
lenses. After reviewing the recommendation of the Ophthalmic Devices
Panel, FDA's Center for Devices and Radiological Health (CDRH) notified
the applicant, by letter of December 22, 1994, of the approval of the
application.
DATES: Petitions for administrative review by August 14, 1996.
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: Donna L. Rogers, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2053.
SUPPLEMENTARY INFORMATION: On May 28, 1993, Alcon Laboratories, Inc.,
Fort Worth, TX 76134-2099, submitted to CDRH an application for
premarket approval of Acrysof Models MA60BM and MA30BA
ultraviolet-absorbing soft acrylic posterior chamber intraocular
lenses. The devices are posterior chamber intraocular lenses and are
indicated for replacement of the human lens to achieve visual
correction of aphakia in patients 60 years of age and older when
extracapsular cataract extraction or phacoemulsification are performed.
These lenses are intended for placement in the capsular bag.
On May 20, 1994, the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On December 22, 1994, CDRH
approved the application by a letter to the applicant from the Director
of the Office of Device Evaluation, CDRH.
[[Page 36888]]
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 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 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 August 14, 1996, file
with the Docket 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 the 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: June 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-17825 Filed 7-12-96; 8:45 am]
BILLING CODE 4160-01-F
