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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEXCOR Pediatric Ventricular Assist Device
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
Berlin Heart Inc.
200 valleywood rd suite b100
the woodlands, TX 77338
PMA NumberP160035
Date Received08/11/2016
Decision Date06/06/2017
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 17M-3580
Notice Date 06/09/2017
Advisory Committee Cardiovascular
Clinical Trials NCT00583661
NCT01674699
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the EXCOR® Pediatric Ventricular Assist Device (referred to as EXCOR Pediatric) 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 Pediatric.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 
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