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 | SILSOFT (ELASTOFILCON A) CONTACT LENSES |
Generic Name | Lens, contact (polymethylmethacrylate) |
Applicant | Bausch & Lomb, Inc. 14853 DEVEAU PLACE MINNETONKA, MN 55345 |
PMA Number | P850068 |
Supplement Number | S001 |
Date Received | 02/02/1987 |
Decision Date | 05/08/1987 |
Product Code |
HPX |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Supplement |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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