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 | MODIFIED J & C LOOP MODEL PA36 |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | EYEKON MEDICAL, INC. 2451 ENTERPRISE RD. CLEARWATER, FL 33763 |
PMA Number | P880072 |
Supplement Number | S026 |
Date Received | 05/16/1995 |
Decision Date | 07/24/1995 |
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 MODELS GS55A-OUV & GS55B-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS AS TIER A MODIFICATIONS OF MODEL PA90E-2UV AND FOR IMPLANTATION IN THE CAPSULAR BAG ONLY |
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