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: SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Alcon Laboratories, Inc.; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P820021
• Supplement Number: S005
• Date Received: 02/05/1986
• Decision Date: 09/21/1987
• Withdrawal Date: 08/28/2019
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No