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 | CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STORZ OPHTHALMICS, INC. 1365 HAMLET AVE. P.O. 2498 CLEARWATER, FL 34616 |
PMA Number | P800017 |
Supplement Number | S004 |
Date Received | 07/30/1987 |
Decision Date | 01/27/1988 |
Withdrawal Date
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06/03/1991 |
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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