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: LIDOFILCON A HYDROPHILIC CONTACT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Advanced Medical Optics, Inc.; 1700 E. St. Andrew Pl.; Santa Ana, CA 92705
• PMA Number: P790020
• Supplement Number: S050
• Date Received: 07/19/1989
• Decision Date: 12/11/1989
• Withdrawal Date: 07/19/2006
• 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