HeartWare HVAD System
FDA premarket approval P100047/S176 · decided 2021-03-30
Approval details
- PMA number
- P100047
- Supplement
- S176
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2021-03-01
- Decision date
- 2021-03-30
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval of an update to an existing in process inspection procedure of the impeller at Medtronic.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Trexon™ Monofilament Synthetic Absorbable Suture (K253530) | Medtronic | 2026-05-28 |
| Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter (K251744) | Medtronic | 2026-01-16 |
| Sphere-9Dx Diagnostic Catheter (AFR-00009) (K233433) | Medtronic | 2024-08-07 |
| 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 |