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. |
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Device | PRISMAFLEX TPE 2000 SET |
Generic Name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
Applicant | BAXTER INTERNATIONAL, INC. 1 BAXTER PKWY. DEERFIELD, IL 60015-4633 |
PMA Number | P830063 |
Supplement Number | S006 |
Date Received | 10/09/2007 |
Decision Date | 06/17/2011 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF 2000N TO PERMIT THE USE OF THE PLASMAFILTER WITH THE GAMBRO PRISMAFLEX SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISMAFLEX TPE 2000 SET AND IS INDICATED FOR THERAPEUTIC PLASMAPHERESIS. |
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