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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 NumberS024
Date Received11/08/2021
Decision Date03/04/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change to the post-conditioning aeration process following Ethylene Oxide sterilization and the addition of another aeration chamber.