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.
 
DeviceHeparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
Generic NameLipoprotein, low density, removal
ApplicantB. Braun Avitum AG
SCHWARZENBERGER WEG 73-79
MELSUNGEN D-342-3421
PMA NumberP940016
Supplement NumberS026
Date Received06/15/2018
Decision Date05/22/2019
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to change the test method for Total Blood Volume (TBV) and to remove TBV acceptance criteria for the batch release of the H.E.L.P. Ultrafilter HIPS 20.
-
-