PMA P240014
- Device
- MAGiC Ablation Catheter
- Applicant
- Stereotaxis, Inc.
- Product code
- LPB
- Decision date
- 2026-01-05
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order 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 in whom vascular or target chamber access by conventional manual catheter navigation is limited due to underlying anatomic abnormalities and/or previous surgical interventions.
Current openFDA PMA Record
- Device
- MAGiC Ablation Catheter
- Applicant
- Stereotaxis, Inc.
- PMA number
- P240014
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2026-01-05
- Decision code
- APPR
- Date received
- 2024-04-12
- Approval order 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 in whom vascular or target chamber access by conventional manual catheter navigation is limited due to underlying anatomic abnormalities and/or previous surgical interventions.