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: B AND L 70 LIDOFILCON A CONTACT LENSE
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Bausch & Lomb, Inc.; 1400 N. Goodman St.; Rochester, NY 14609
• PMA Number: P880029
• Supplement Number: S001
• Date Received: 06/10/1988
• Decision Date: 03/13/1989
• Withdrawal Date: 04/22/2009
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No