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 MODELS 24050,24150,25050,25350-125 LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | EYETECH, LLC. 7016 6TH ST. NORTH OAKDALE, MN 55128 |
PMA Number | P880082 |
Supplement Number | S013 |
Date Received | 05/24/1991 |
Decision Date | 08/06/1991 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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