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 | SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920) |
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 | P940007 |
Supplement Number | S004 |
Date Received | 07/31/1998 |
Decision Date | 09/29/1998 |
Withdrawal Date
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01/22/2008 |
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 for a manufacturing site located at Pharmacia & Upjohn Groningen BV, Van Swietenlaan 5, NL-9728, NX Groningen, The Netherlands. |
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