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 | SOFLENS66(TM) |
Generic Name | Lenses, soft contact, extended wear |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P960022 |
Supplement Number | S001 |
Date Received | 08/07/1997 |
Decision Date | 09/30/1997 |
Product Codes |
LPL LPM |
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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