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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
Classification Nameventricular (assist) bypass
Generic Nameventricular (assist) bypass
Berlin Heart Inc.
9391 grogan's mill road, suite a-6
the woodlands, TX 77380
PMA NumberP160035
Supplement NumberS005
Date Received04/10/2019
Decision Date08/05/2019
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the wiring system at the nurse call relay switch of the EXCOR IKUS driver.