• 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.
 
DeviceGAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Applicant
BAXTER INTERNATIONAL, INC.
1 baxter pkwy.
deerfield, IL 60015-4633
PMA NumberP830063
Supplement NumberS002
Date Received01/18/2000
Decision Date08/28/2002
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATIONS TO THE REQUIREMENTS OF THE POST-MARKET STUDY FOR THE DEVICE.
Post-Approval StudyShow Report Schedule and Study Progress
-
-