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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 Ventricular Assist System
Generic Nameventricular (assist) bypass
ApplicantMedtronic
8200 coral seast. n.e.
mounds view, MN 55112
PMA NumberP100047
Supplement NumberS192
Date Received02/08/2022
Decision Date03/01/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of a visual inspection step in splice kit assembly procedure.
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