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 | POSTERIOR CHAMBER IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840060 |
Supplement Number | S022 |
Date Received | 02/17/1993 |
Decision Date | 02/20/1996 |
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 A NUMBER OF TIER A MODELS. THE MODELS LISTED IN ATTACHMENT 1 ARE INTENDED FOR BOTH CILIARY SULCUS AND CAPSULAR BAG IMPLANTATION; MODELS LX10BD AND MZ40BD ARE INTENDED FOR CAPSULAR BAG IMPLANTATION ONLY |
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