HeartWare HVAD System
FDA premarket approval P100047/S235 · decided 2026-04-07
Approval details
- PMA number
- P100047
- Supplement
- S235
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2025-11-21
- Decision date
- 2026-04-07
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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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