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: NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Alcon Laboratories, Inc.; 6201 South Freeway; Fort Worth, TX 76134-2099
• PMA Number: P820021
• Supplement Number: S021
• Date Received: 03/28/1990
• Decision Date: 08/17/1990
• Withdrawal Date: 08/28/2019
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No