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: DANKER SILICONE LENS (DIMEFOCON-A)
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Ciba Vision Corporation; 11460 Johns Creek Pkwy.; Duluth, GA 30097
• PMA Number: P790010
• Supplement Number: S005
• Date Received: 05/25/1984
• Decision Date: 08/16/1985
• Withdrawal Date: 05/12/2009
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No