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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 Left Ventricular Assist System
Generic NameVentricular (assist) bypass
ApplicantMedtronic
8200 Coral SeaSt. N.E.
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS163
Date Received05/22/2020
Decision Date11/18/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the Instructions for Use and Patient Manual as a result of remediation activities.
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