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: AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
• Generic Name: Lens, contact (polymethylmethacrylate)
• Applicant: Ciba Vision Corporation; 11460 Johns Creek Pkwy.; Duluth, GA 30097
• PMA Number: P830070
• Supplement Number: S011
• Date Received: 02/29/1988
• Decision Date: 05/05/1988
• Withdrawal Date: 05/12/2009
• Product Code: HPX
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No