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: CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Storz Ophthalmics, Inc.; 1365 Hamlet Ave.; P.O. 2498; Clearwater, FL 34616
• PMA Number: P800017
• Supplement Number: S003
• Date Received: 03/16/1987
• Decision Date: 09/21/1987
• Withdrawal Date: 06/03/1991
• 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