|
Device | 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 | S008 |
Date Received | 07/24/2006 |
Decision Date | 05/24/2007 |
Product Code |
NAA |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement PERFORM MOIST HEAT STERILIZATION IN HOUSE AT EYEONICS? RANCHO CUCAMONGA FACILITY. |