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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 NumberS013
Date Received09/11/2015
Decision Date11/17/2015
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for changes to the device labeling. The device, as modified, will be marketed under the trade name berlin heart excor pediatric ventricularassist device and is indicated for the following:excor pediatric ventricular assist device (referred to as excor) is intended to providemechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who arecandidates for cardiac transplant and require circulatory support may be treated using the excor.
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