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 & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | BAUSCH & LOMB 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P870013 |
Supplement Number | S008 |
Date Received | 10/31/1995 |
Decision Date | 05/01/1996 |
Withdrawal Date
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04/06/2009 |
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 OF THE FOLLOWING: IMPLEMENTATION OF NEW MANUFACTURING PROCESSES OF CLEAR AND VIOLET HAPTIC POLYMETHYLMETHACRYLATE (PMMA) ONE-PIECE POSTERIOR CHAMBER LENSES; THE USE OF A NEW TUMBLING PROCESS FOR YOUR THREE-PIECE LENSES; AND THE INTRODUCTION OF SEVERAL TIER A POSTERIOR CHAMBER LENSES, MODELS 8192, 8490B, 8492B, 8090B, 8091B, 8193B, 8491B, 8493B, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B |
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