Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: DURASOFT 3 (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
• Classification Name: lenses, soft contact, extended wear
• Generic Name: soft (hydrophilic) contact lens
• Regulation Number: 886.5925
• Applicant: CIBA VISION CORPORATION
• PMA Number: P830037
• Supplement Number: S051
• Date Received: 12/13/2010
• Decision Date: 01/11/2011
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Alternate supplier for methacrylic acid (maa).