Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TIER A UV-ABSORBING POSTERIOR CHAMBER INTARA. LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Irvine, CA 92618 |
PMA Number | P840039 |
Supplement Number | S030 |
Date Received | 08/19/1991 |
Decision Date | 02/07/1996 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF D & C GREEN NO.6 DYE TO THE HAPTICS OF THE SINGLE-PIECE POLYMETHYLMETHACRYLATE (PMMA) IOLS UNDER THIS PMA AND MANUFACTURED FROM PMMA SUPPLIED FROM THE ST. LOUIS FACILITY |
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