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 | REVOLUTION(TM) (METHAFILCON A) HYDROPHILIC LENS |
Generic Name | Lenses, soft contact, daily wear |
Regulation Number | 886.5925 |
Applicant | COOPER VISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
PMA Number | P850077 |
Supplement Number | S015 |
Date Received | 02/21/1991 |
Decision Date | 08/27/1991 |
Withdrawal Date
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05/01/2014 |
Product Code |
LPL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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