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Device | COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | COOPERVISION, INC. 370 WOODCLIFF DRIVE SUITE 200 FAIRPORT, NY 14450-0000 |
PMA Number | P850079 |
Supplement Number | S063 |
Date Received | 12/10/2012 |
Decision Date | 02/21/2014 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MANUFACTURE OF THE DEVICE ON ANOTHER MANUFACTURING LINE AND FURTHER THAT ORDERS WITH LOW VOLUME REQUIREMENTS WILL BE LATHED ON THE FRONT SURFACE, RATHER THAN FULLY MOLDED AS LARGE VOLUME ORDERS ARE. |