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: MIRASOL(TM)
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Wesley Jessen Corp.; 400 W. Superior St.; Chicago, IL 60610
• PMA Number: P810008
• Supplement Number: S006
• Date Received: 02/03/1986
• Decision Date: 06/17/1986
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No