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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceMAGiC Ablation Catheter
Generic NameCardiac ablation percutaneous catheter
ApplicantStereotaxis, Inc.
710 Tucker Blvd.
Suite 110
Saint Louis, MO 63101
PMA NumberP240014
Date Received04/12/2024
Decision Date01/05/2026
Product Code LPB 
Docket Number 26M-0130
Notice Date 01/06/2026
Advisory Committee Cardiovascular
Clinical TrialsNCT06019845
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
Post-Approval StudyShow Report Schedule and Study Progress
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