HELIOS II ABLATION CATHETER
FDA premarket approval P050029 · decided 2008-10-10
Approval details
- PMA number
- P050029
- Trade name
- HELIOS II ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Stereotaxis, Inc.
- Date received
- 2005-08-23
- Decision date
- 2008-10-10
- Days to decision
- 1144 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- APPROVAL FOR THE HELIOS II ABLATION CATHETER. THE HELIOS II ABLATION CATHETER IS INTENDED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING, DELIVERING DIAGNOSTIC PACING STIMULI, AND FOR THE CREATION OF ENDOCARDIAL LESIONS TO TREAT PATIENTS WITH SUPRAVENTRICULAR (SVT) TACHYCARDIAS.IT IS INTENDED TO ELIMINATE ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) IN PATIENTS WITH OVERT OR CONCEALED ACCESSORY PATHWAYS, TO ELIMINATE AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT), AND TO CREATE COMPLETE AV NODAL BLOCK IN PA
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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 |