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: S002
• Date Received: 12/15/1982
• Decision Date: 09/15/1983
• Withdrawal Date: 05/12/2009
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No