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) CONTACT LENS FOR EXTENDED WEAR |
Generic Name | Lenses, soft contact, extended wear |
Applicant | COOPERVISION, INC. 370 WOODCLIFF DRIVE SUITE 200 FAIRPORT, NY 14450-0000 |
PMA Number | P850079 |
Supplement Number | S041 |
Date Received | 08/20/2002 |
Decision Date | 02/12/2003 |
Product Codes |
LPM MVN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT COOPERVISION, INC., NORFOLK, VIRGINIA. |
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