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: CRYOMAX(TM)
• Generic Name: Separator, automated, blood cell and plasma, therapeutic
• Applicant: Strato Medical Corp.; Pfizer Hospital Products Group; 123 Brimbal Ave.; Beverly, MA 01915
• PMA Number: P820002
• Supplement Number: S002
• Date Received: 05/02/1983
• Decision Date: 08/03/1983
• Product Code: LKN
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No