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: DURASOFT(R) TRUFOCAL(TM)
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Wesley Jessen Corp.; 400 W. Superior St.; Chicago, IL 60610
• PMA Number: N17852
• Supplement Number: S008
• Date Received: 07/22/1982
• Decision Date: 04/20/1983
• Product Code: LPL
• Notice Date: 06/03/1983
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No