Cardiac Ablation Percutaneous Catheter
Basic Information
- Device Name
- Cardiac Ablation Percutaneous Catheter
- Trade Name
- MAGiC Ablation Catheter
- PMA Number
- P240014
- Device Class
- FDA Class 3
- Product Code
- LPB
- Generic Name
- Cardiac ablation percutaneous catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 5, 2026
- Date Received
- April 12, 2024
- Expedited Review
- N
- Docket Number
- 26M-0130
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPB | Cardiac Ablation Percutaneous Catheter | FDA class 3 | Unknown |