HeartWare® Ventricular Assist System
FDA premarket approval P100047/S209 · decided 2023-04-26
Approval details
- PMA number
- P100047
- Supplement
- S209
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartWare® Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2023-03-31
- Decision date
- 2023-04-26
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Move the charging process and storage of the HVAD Monitors from Arrow Electronics to Medtronics Miami Lakes Facility. The address of the facility is the current approved location: HeartWare, Inc. 14400 NW 60th Ave. Miami Lakes, FL33014
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 |