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 | SOFLENS(R) (POLYMACON) P.A.1 SERIES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | N16895 |
Supplement Number | S019 |
Date Received | 10/19/1981 |
Decision Date | 11/16/1982 |
Product Code |
LPM |
Notice Date | 12/17/1982 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
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