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: VANTAGE & VANTAGE THIN (TETRAFILCON A) CONTACT LEN
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: CooperVision, Inc.; 6150 Stoneridge Mall Rd.; Suite 370; Pleasanton, CA 94588
• PMA Number: N17679
• Supplement Number: S025
• Date Received: 03/21/1991
• Decision Date: 09/13/1991
• Product Code: LPM
• 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
• Predetermined Change Control Plan Authorized: No