PMA P240014S001

Device: MAGiC Ablation Catheter
Applicant: Stereotaxis, Inc.
PMA number: P240014
Supplement: S001
Product code: LPB
Decision date: 2026-07-31
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
Approval order 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.

Current openFDA PMA Record#

Device: MAGiC Ablation Catheter
Applicant: Stereotaxis, Inc.
PMA number: P240014
Supplement: S001
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2026-07-31
Decision code: APPR
Date received: 2026-02-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order 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.