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 | ADAPETTES |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | N17945 |
Supplement Number | S028 |
Date Received | 08/16/1995 |
Decision Date | 09/08/1995 |
Withdrawal Date
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12/22/2003 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TOINLCUDE ELIMINATING AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS |
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