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: PHEMFILCON A
• 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: S046
• Date Received: 07/16/2002
• Decision Date: 09/04/2002
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a labeling modification of the secondary box carton to include the claim "improved comfort".