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Device | STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P880091 |
Supplement Number | S029 |
Date Received | 12/12/2008 |
Decision Date | 01/09/2009 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REPLACEMENT OF THE CURRENT FILTER USED DURING THE FILTERING PROCESS OF THE RMX-3 SILICONE BASE MATERIAL. |