• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM
Classification Namelipoprotein, low density, removal
Generic Nameblood line sets for the heparin-induced extracorporeal ldl preciitation system.
ApplicantB. BRAUN OF AMERICA, INC.
PMA NumberP940016
Supplement NumberS004
Date Received12/15/1998
Decision Date08/12/1999
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for administering the sf-36 quality of life (qol) survey on an annual basis, instead of on a quarterly basis, of rthe patient registry/post approval study of the h. E. L. P. System.
-
-