|
Device | CLEARSOFT (METHAFILCON A) SOFT COTACT LENS |
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 | S050 |
Date Received | 08/16/2011 |
Decision Date | 12/20/2011 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD THE PRIVATE LABEL NAME AQUATECH PREMIUM TO THE LIST OF APPROVED NAME FOR THE DEVICE. |