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 | S070 |
Date Received | 06/23/1998 |
Decision Date | 07/15/1998 |
Withdrawal Date
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04/15/2009 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new test method and specification for ethylene oxide residuals prior to product release. |
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