HeartWare HVAD System
FDA premarket approval P100047/S227 · decided 2025-07-09
Approval details
- PMA number
- P100047
- Supplement
- S227
- 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
- 2025-04-10
- Decision date
- 2025-07-09
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for updating the minimum joint torque strength limits against disassembly torque for the motor connector port on the HVAD controller
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510(k) clearances by this applicant
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|---|---|---|
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| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated (K240190) | Medtronic | 2024-02-23 |
| CD Horizon Spinal System (K223494) | Medtronic | 2023-01-23 |
| SelectSite C304 Deflectable Catheter System, C315 Delivery System (K223178) | Medtronic | 2022-11-08 |
| Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system (K222873) | Medtronic | 2022-11-07 |
| CD Horizon™ Spinal System (K221244) | Medtronic | 2022-05-25 |