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: SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)
• 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: S037
• Date Received: 12/23/1999
• Decision Date: 09/18/2000
• Withdrawal Date: 06/05/2013
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Express GMP Supplement
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.