Premarket Approval (PMA)

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.

• Device: COOPERVISION METHAFILCON AB 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: S056
• Date Received: 08/24/2012
• Decision Date: 09/18/2012
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
NEW MANUFACTURING LINE.