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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 NumberS013
Date Received01/24/2020
Decision Date09/23/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to the polyurethane (PU) membrane and supplier/supplier production site change for the PU solutions.
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