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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 NumberS007
Date Received03/07/2013
Decision Date08/29/2013
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 primary/secondary packaging and labeling for the contegra pulmonary valved conduit (models 200 and 200s).
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