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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 NameEXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE
Applicant
Berlin Heart, Inc.
200 valleywood
suite b100
the woodlands, TX 77380
HDE NumberH100004
Supplement NumberS003
Date Received01/17/2012
Decision Date07/27/2012
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post-approval study protocol.
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