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Device | UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER 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 | S011 |
Date Received | 08/14/1997 |
Decision Date | 07/20/1998 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to package the MicroSTAAR injector cartridges with the ELASTIMIDE(TM) lenses, and for a five-year shelf life for the cartridges sterilized via your new ethylene oxide (EtO) cycle. |