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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.
 
DeviceHeartWare HVAD System
Generic Nameventricular (assist) bypass
ApplicantMedtronic
8200 coral seast. n.e.
mounds view, MN 55112
PMA NumberP100047
Supplement NumberS196
Date Received04/07/2022
Decision Date09/30/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a modification to the HVAD Battery configuration mode and changes to the Battery Pack Final Tester software
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