Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DevicePRISMA TPE 2000 SET
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.
1 BAXTER PKWY.
DEERFIELD, IL 60015-4633
PMA NumberP830063
Supplement NumberS005
Date Received11/24/2006
Decision Date06/19/2009
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PRISMA TPE 2000 SET: 1) DIRECT CONNECTION OF THE PLASMAFILTER TO THE CARTRIDGE PLATE VIA THE DIALYSATE CONNECTORS; 2) OPTIMIZATION AND SIMPLIFICATION OF THE TUBING CIRCUIT; 3) THE PLASMAFILTER ORIENTED PARALLEL TO THE CARTRIDGE PLATE; 4) THE LINES FIXED BY PAWL AND RATCHET MECHANISM; 5) THE PUMP SEGMENT FIXED BY CLICKING VIA A SPECIFIC JOINT CONNECTOR; AND 6) BLOOD LINES SCREWED BY CONNECTORS TO THE BLOOD PORT FILTER.
-
-