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 | CUSTOMEYES(TM) 45L&55L (BUFILCON A) |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY DULUTH, GA 30097 |
PMA Number | P850057 |
Supplement Number | S001 |
Date Received | 07/28/1986 |
Decision Date | 05/08/1987 |
Withdrawal Date
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06/10/2009 |
Product Code |
LPM |
Docket Number | 87M-0191 |
Notice Date | 06/29/1987 |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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