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: X-70 SOFT CONTACT LENS
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Advanced Medical Optics, Inc.; 1700 E. St. Andrew Pl.; P.O. Box 25162; Santa Ana, CA 92705
• PMA Number: P830047
• Supplement Number: S003
• Date Received: 08/04/1987
• Decision Date: 01/20/1988
• Withdrawal Date: 09/14/2007
• 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