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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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.
 
Trade NameMICROMED HEART ASSIST 5 PEDIATRIC VAD LEFT VENTRICULAR ASSIST DEVICE
Classification Nameventricular (assist) bypass
Generic Nameventricular (assist) bypass
Applicant
Reliantheart, Inc.
8965 interchange dr.
houston, TX 77054
HDE NumberH030003
Supplement NumberS010
Date Received05/26/2010
Decision Date10/01/2010
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post-approval study protocol.
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