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: GELFLEX(R) (DIMEFILCON A) CONTACT LENS
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Dow Corning Ophthalmics, Inc.; P.O. Box 1767; Midland, MI 48640
• PMA Number: N17722
• Supplement Number: S005
• Date Received: 07/23/1981
• Decision Date: 02/26/1982
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No