Sphere-9 Catheter and Affera Ablation System
FDA premarket approval P240013 · decided 2024-10-24
Approval details
- PMA number
- P240013
- Trade name
- Sphere-9 Catheter and Affera Ablation System
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Medtronic, Inc.
- Date received
- 2024-04-11
- Decision date
- 2024-10-24
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for the Sphere-9 Catheter and Affera Ablation System. This device is indicated for use in cardiac electrophysiological mapping (stimulation and electrogram recording) and for treatment of drug refractory, recurrent, symptomatic persistent atrial fibrillation (episode duration less than 1 year) and radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter when used with the Affera mapping system.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |