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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
Classification Nameventricular (assist) bypass
Generic Nameventricular (assist) bypass
Applicant
Berlin Heart Inc.
200 valleywood
suite b100
the woodlands, TX 77380
HDE NumberH100004
Supplement NumberS011
Date Received07/28/2014
Decision Date10/03/2014
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a change to the driveline used with the excorpediatric blood pump.
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