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: CABCURVE (POROFOCAN B)
• Generic Name: Lens, contact (polymethylmethacrylate)
• Applicant: Wesley Jessen Corp.; 333 E. Howard Ave.; Des Plaines, IL 60018
• PMA Number: N18032
• Supplement Number: S006
• Date Received: 04/05/1983
• Decision Date: 10/25/1983
• Product Code: HPX
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No