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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceEXCOR Pediatric Ventricular Assist Device
Generic Nameventricular (assist) bypass
ApplicantBerlin Heart Inc.
9391 grogan's mill road, suite a-6
the woodlands, TX 77380
PMA NumberP160035
Supplement NumberS028
Date Received07/15/2022
Decision Date08/12/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacturing change to the printed circuit board used in the Berlin Heart EXCOR IKUS Driver.