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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 NumberS200
Date Received05/26/2022
Decision Date09/08/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT01966458
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for various updates to the Instructions for Use to add the final clinical results of the post-approval studies entitled Newly Enrolled (HW-PAS-01) Training Program (HeartWare-PAS-02), and Cont F/u of HW004-A ENDURANCE.
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