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: MODEL AC10 & AC20 IOLS
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Advanced Medical Optics, Inc.; 1700 E. St. Andrew Pl.; P.O. Box 25162; Santa Ana, CA 92705
• PMA Number: P810056
• Supplement Number: S007
• Date Received: 05/03/1988
• Decision Date: 08/16/1988
• Withdrawal Date: 04/15/2009
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No