MAGiC Ablation Catheter
FDA premarket approval P240014/S001 · decided 2026-07-31
Approval details
- PMA number
- P240014
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MAGiC Ablation Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Stereotaxis, Inc.
- Date received
- 2026-02-04
- Decision date
- 2026-07-31
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saint Louis, MO
- Statement
- approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240014.
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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 |