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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 Sea St. N.E
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS235
Date Received11/21/2025
Decision Date04/07/2026
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 changes to the HVAD Battery Pack including: 1) adjusting the State of Charge (SOC) to no greater than 30%, 2) enabling the Sleep Mode feature before packaging and shipping, 3) adding a new ICAO Packing Instruction (PI) 966 for UN3481, 4) adding a ‘Sleep Mode Battery Charger/Discharger’ as a new manufacturing process equipment, and 5) discontinuing the HVAD Batteries recharge process.
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