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: PROSORBA(TM) COLUMN
• Classification Name: separator, automated, blood cell and plasma, therapeutic
• Generic Name: therapeutic plasma exchange
• Applicant: IMRE CORP.
• PMA Number: P850020
• Supplement Number: S006
• Date Received: 03/15/1993
• Decision Date: 04/29/1993
• Product Code: LKN [ Registered Establishments with LKN ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No