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Device | EYEONICS CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) |
Generic Name | Lens, intraocular, accommodative |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S009 |
Date Received | 03/05/2007 |
Decision Date | 06/29/2007 |
Product Code |
NAA |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR RECOMMENDATION TO USE THE STAAR MSI-PF INJECTOR AND MTC-60C CARTRIDGE SYSTEM FOR INJECTING THE CRYSTALENS MODELS AT-45 & AT-45SE) TO BE ADDED TO THE PHYSICIAN LABELING. |