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 | DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY DULUTH, GA 30097 |
PMA Number | P850072 |
Supplement Number | S002 |
Date Received | 11/12/1987 |
Decision Date | 02/24/1988 |
Withdrawal Date
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05/12/2009 |
Product Code |
LPM |
Docket Number | 88M-0082 |
Notice Date | 03/30/1988 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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