Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: PLASMAFLO AP-05H ASAHI PLASMA SEPARATOR
• Classification Name: separator, automated, blood cell and plasma, therapeutic
• Generic Name: plasma separator
• Applicant: ASAHI CHEMICAL INDUSTRY AMERICA,INC.
• PMA Number: P820033
• Supplement Number: S001
• Date Received: 04/20/1984
• Decision Date: 01/08/1986
• Product Code: LKN [ Registered Establishments with LKN ]
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No