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Device | ELASTIMIDE UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P880091 |
Supplement Number | S016 |
Date Received | 01/22/1999 |
Decision Date | 08/31/1999 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for lens Model AQ-5010V in the power range of -4.0 to +4.0 diopters in 1.0 diopter increments. |