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: PROSORBA TREATMENT COLUMN FOR RA AND ITP
• Generic Name: Separator, automated, blood cell and plasma, therapeutic
• Applicant: Fresenius Hemocare, Inc.; 920 Winter St.; Waltham, MA 02451
• PMA Number: P850020
• Supplement Number: S012
• Date Received: 06/21/1999
• Decision Date: 12/17/1999
• Withdrawal Date: 04/14/2008
• Product Code: LKN
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of post-approval study protocols.