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 | MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 SANTA ANA, CA 92705-4933 |
PMA Number | P860034 |
Supplement Number | S014 |
Date Received | 11/13/1995 |
Decision Date | 03/11/1996 |
Withdrawal Date
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11/20/2006 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGIN CONFIGURATIO CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA (SSG) |
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