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: FLEXSOL
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Alcon Laboratories; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: N17974
• Supplement Number: S024
• Date Received: 05/16/1980
• Decision Date: 05/16/1980
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Special (Immediate Track)
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No