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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 NumberS166
Date Received06/05/2020
Decision Date09/03/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the IFU regarding the replacement of the Monitor when the Monitor Battery no longer holds a sufficient charge.
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