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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 NumberS057
Date Received03/03/2026
Decision Date10/01/2026
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the implementation of dynamic viscosity measurement with specification limits for silicone coating solution used in the manufacture of EXCOR® cannulae and connecting/extension sets
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