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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received06/18/2010
Decision Date12/16/2011
Product Code
PCK[ Registered Establishments with PCK ]
Docket Number 11M0919
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the berlin heart excor® pediatric ventricular assist device (vad). This device is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the excor.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S016 S017 S018 
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