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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.
Classification Namepediatric ventricular assist device
Generic Namepediatric ventricular assist device
Regulation Number870.3545
Berlin Heart Inc.
200 valleywood
suite b100
the woodlands, TX 77380
HDE NumberH100004
Supplement NumberS017
Date Received05/03/2016
Decision Date07/14/2016
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 to (1) replace two sealing machines used for sealing the tyvek sterile packaging pouches and reels used for packaging the excor sterile components and (2) modify the seal strength specification for the sterile packaging pouches for the excor sterile components.