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 PARKWAY; DULUTH, GA 30097
• PMA Number: N17752
• Supplement Number: S034
• Date Received: 08/08/1989
• Decision Date: 09/08/1989
• Withdrawal Date: 06/05/2013
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No