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 | S030 |
Date Received | 05/26/1995 |
Decision Date | 08/24/1995 |
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 RESPONSE TO FDA'S LETTER OF APRIL 28, 1995, RE:YOUR 1992 AND 1993 ANNUAL REPORTS & REQUESTED TIER A APPROVAL FOR MDLS:GL55A-OUV, GL55B-OUV,PS40D-OUV,PS60C-OUV,PB61B-OUV,PB07C-OUV & LP57L-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS |
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