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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 (assist) bypass
Generic Nameventricular (assist) bypass
Applicant
Medtronic
8200 coral seast. n.e.
mounds view, MN 55112
PMA NumberP100047
Supplement NumberS115
Date Received10/30/2017
Decision Date07/26/2018
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This device is indicated for hemodynamic support in patients with advanced, refractory leftventricular 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. We are pleased to inform you that the PMA supplement is approved.
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