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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 NumberS027
Date Received07/05/2022
Decision Date08/04/2022
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  
Removing the additional output test in the EXCOR blood pumps production line.