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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 NumberS018
Date Received07/05/2016
Decision Date09/15/2016
Product Code
PCK[ Registered Establishments with PCK ]
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 velour fabric used during manufacturing of berlin heart excor pediatric ventricular assist device cannulae.
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