MAGiC Ablation Catheter
FDA premarket approval P240014 · decided 2026-01-05
Approval details
- PMA number
- P240014
- Trade name
- MAGiC Ablation Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Stereotaxis, Inc.
- Date received
- 2024-04-12
- Decision date
- 2026-01-05
- Days to decision
- 633 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saint Louis, MO
- Statement
- approval for the MAGiC Ablation Catheter. This device is indicated for: The MAGiC Magnetic Interventional Ablation Catheter is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and for the creation of endocardial lesions to treat supraventricular tachycardia (e.g., macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia) in patients with congenital heart disease i
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Synchrony (K253473) | Stereotaxis, Inc. | 2026-04-01 |
| Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (K251792) | Stereotaxis, Inc. | 2025-11-06 |
| MAGiC Sweep™ EP Mapping Catheter (K250590) | Stereotaxis, Inc. | 2025-07-23 |
| Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (K193147) | Stereotaxis, Inc. | 2020-03-05 |
| Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775) | Stereotaxis, Inc. | 2019-10-30 |
| Steerable catheter control system (K183027) | Stereotaxis, Inc. | 2019-09-06 |
| Vdrive system, Vdrive Duo, Vdrive with V-Sono (K150312) | Stereotaxis, Inc. | 2015-06-17 |
| VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS (K141530) | Stereotaxis, Inc. | 2014-12-18 |