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: PLASMA SEPARATION SYSTEM
• Generic Name: Separator, automated, blood cell and plasma, therapeutic
• Applicant: Fenwal, Inc.; Three Corporate Dr.; Lake Zurich, IL 60047
• PMA Number: P820032
• Supplement Number: S002
• Date Received: 04/30/1984
• Decision Date: 06/13/1984
• Withdrawal Date: 07/10/2014
• Product Code: LKN
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No