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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 Rd.
Suite A-6
The Woodlands, TX 77380
PMA NumberP160035
Supplement NumberS059
Date Received07/08/2026
Decision Date08/05/2026
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the use of polyurethane (PU) to seal the de-airing port plug on EXCOR blood pumps
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