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: NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES
• Classification Name: lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: CIBA VISION CARE
• PMA Number: P820021
• Supplement Number: S022
• Date Received: 10/31/1990
• Decision Date: 01/14/1992
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No