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 | METHAFILCON A |
Generic Name | Lenses, soft contact, extended wear |
Applicant | COOPERVISION, INC. 370 WOODCLIFF DRIVE SUITE 200 FAIRPORT, NY 14450-0000 |
PMA Number | P850079 |
Supplement Number | S034 |
Date Received | 02/02/2000 |
Decision Date | 05/05/2000 |
Product Codes |
LPM MVN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval of a protocol to extend the shelf life of methafilcon A blister packaged products from three years to six years. |
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