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 | UV ABSORBING POSTERIOR CHAMBER IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P810018 |
Supplement Number | S034 |
Date Received | 01/30/1995 |
Decision Date | 07/24/1995 |
Withdrawal Date
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12/20/2002 |
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 THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS |
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