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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
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
Medtronic
8200 coral seast. n.e.
mounds view, MN 55112
PMA NumberP100047
Supplement NumberS090
Date Received01/31/2017
Decision Date09/27/2017
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 17M-5968
Notice Date 10/05/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01166347
NCT01966458
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the HeartWare HVAD System. This device is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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