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 SOFT HYDROPHILIC SPERICAL/TORIC CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Applicant | COOPERVISION, INC. 370 WOODCLIFF DRIVE SUITE 200 FAIRPORT, NY 14450-0000 |
PMA Number | P850079 |
Supplement Number | S032 |
Date Received | 09/28/1999 |
Decision Date | 11/24/1999 |
Product Codes |
LPM MVN |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for adding disposable and frequent/planned replacement to the wearing schedule. |
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