• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

  • 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 supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
Classification Nameventricular (assist) bypass
Generic Nameventricular (assist) bypass
8965 interchange drive
houston, TX 77054
HDE NumberH030003
Supplement NumberS009
Date Received03/15/2010
Decision Date04/15/2010
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for cheanging the device trade name from the debakey vad® child l-eft ventricular assist device to 1-i -artassist® 5 pediatric vad. The device, asmodified, will he marketed under the trade name heartassist® 5 pediatric vad and is indicated for use to provide temporary left side mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients (5-16 yeas old, with bsa > 0. 7 m ~and < 1. 5 1in 2) who are in nyha class iv end stage heart failure, are refractory to medical therapy and \vho are (listed) candidates for cardiac transplantation.