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: SOFTMARK
• Generic Name: System, identification, contact lens
• Applicant: Ciba Vision Corporation; 11460 Johns Creek Pkwy.; Duluth, GA 30097
• PMA Number: P820027
• Supplement Number: S001
• Date Received: 08/04/1983
• Decision Date: 11/01/1983
• Withdrawal Date: 09/22/2009
• Product Code: LOH
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No