HeartWare Ventricular Assist (HVAD) System
FDA premarket approval P100047/S195 · decided 2022-03-16
Approval details
- PMA number
- P100047
- Supplement
- S195
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartWare Ventricular Assist (HVAD) System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2022-02-15
- Decision date
- 2022-03-16
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the clinician Instructions for Use (IFU) and the Patient Manual (PM) to add clarity with regard to cleaning certain components of the HVAD System
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |