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Device | ELASTIC AND ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
Regulation Number | 886.3600 |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P880091 |
Supplement Number | S015 |
Date Received | 09/17/1998 |
Decision Date | 03/15/1999 |
Product Code |
MJP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification to the manufacturing process. |