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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 Namepediatric ventricular assist device
Generic Namepediatric ventricular assist device
Regulation Number870.3545
Applicant
Berlin Heart, Inc.
200 valleywood
suite b100
the woodlands, TX 77380
HDE NumberH100004
Supplement NumberS016
Date Received03/14/2016
Decision Date07/20/2016
Product Code
PCK[ Registered Establishments with PCK ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a change in supplier for the dc to dc converter printed circuit board used in the ikus driving unit.
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