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Device | UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC |
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 | S014 |
Date Received | 12/16/1997 |
Decision Date | 11/04/1998 |
Product Code |
MJP |
Docket Number | 98M-0998 |
Notice Date | 12/17/1998 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement This device is indicated for improving uncorrected visual acuity, correcting aphakia and decreasing refractive cylinder resulting from corneal astigmatism in persons aged 60 and over. |