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Device | UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P880091 |
Supplement Number | S009 |
Date Received | 05/28/1996 |
Decision Date | 11/14/1996 |
Product Code |
HQL |
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 ADDITION OF AN ALTERNATE STEAM STERILIZER AND REVERSE OSMOSIS UNIT TO YOUR STERILIZATION PROCESS |