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 | MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS |
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 | P810055 |
Supplement Number | S067 |
Date Received | 03/06/1997 |
Decision Date | 05/28/1997 |
Withdrawal Date
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04/15/2009 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL 777A. THIS INTRAOCULAR LENS IS INDICATED FOR USE IN THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE AND OLDER, WHO ARE UNDERGOING A PRIMARY LENS IMPLANTATION, IN EITHER THE CILIARY SULCUS OR CAPSULAR BAG FOLLOWING AN EXTRACAPSULAR CATARACT EXTRACTION. |
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