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: SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Dow Corning Corp. Healthcare Industries Materials; P.O. Box 2693; Norfolk, VA 23501
• PMA Number: P800054
• Supplement Number: S009
• Date Received: 11/30/1983
• Decision Date: 03/12/1984
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No