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: HYDROCURVE
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Ciba Vision Corporation; 11460 Johns Creek Pkwy.; Duluth, GA 30097
• PMA Number: N17752
• Supplement Number: S019
• Date Received: 10/26/1983
• Decision Date: 01/12/1984
• Withdrawal Date: 06/05/2013
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No