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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 Sea St. N.E
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS239
Date Received05/05/2026
Decision Date07/28/2026
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following design and manufacturing changes related to the HeartWare Ventricular Assist System’s Battery Charger AC Adapter: i) Component changes on the AC Adapter printed circuit board assembly (PCBA), ii) Addition of a ferrite component to the AC Adapter cable, and iii) Implementation of a new rework process for replacing the power supply of the AC Adapter.
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