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: MINITHEERM
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Ciba Vision Care; 11460 Johns Creek Pkwy.; Duluth, GA 30136
• PMA Number: N18001
• Supplement Number: S004
• Date Received: 09/18/1981
• Decision Date: 04/19/1982
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No