Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS |
Generic Name | Lens, intraocular, accommodative |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S020 |
Date Received | 06/02/2009 |
Decision Date | 08/05/2011 |
Product Code |
NAA |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO MARKET CRYSTALENS® MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) WITH A BENZOTRIAZOLE ULTRA-VIOLET (UV) ABSORBER CHROMOPHORE (UVAM). TO BE DESIGNATED AS MODELS AT1UV, AT2UV, HD1UV, HD2UV, AO1UV AND AO2UV. |
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