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: KONTUR SOFT (METHAFILCON A) LENS
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Kontur Kontact Lens Co., Inc.; 642 Alfred Nobel Dr.; Hercules, CA 94547
• PMA Number: P850078
• Supplement Number: S010
• Date Received: 08/23/1988
• Decision Date: 03/14/1989
• Withdrawal Date: 04/27/2015
• Product Code: LPL
• 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