← Product Code LPB · P240014 # MAGiC Ablation Catheter (P240014) _Stereotaxis, Inc. · LPB · Jan 5, 2026 · Cardiovascular · APPR_ **Canonical URL:** https://fda.innolitics.com/device/P240014 ## Device Facts - **Applicant:** Stereotaxis, Inc. - **Product Code:** LPB - **Decision Date:** Jan 5, 2026 - **Decision:** APPR - **Device Class:** Class 3 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use 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. ## Device Story MAGiC Ablation Catheter facilitates cardiac electrophysiological mapping, diagnostic pacing, and endocardial lesion creation. Designed for patients with congenital heart disease where conventional manual navigation is restricted by anatomy or prior surgery. Operates as part of a system including a compatible radiofrequency (RF) generator, irrigation pump, and robotic magnetic navigation system. Used by clinicians in clinical settings to treat SVT. Robotic magnetic navigation allows precise catheter positioning in complex anatomies. Output consists of RF energy delivery for tissue ablation. Benefits include enabling minimally invasive treatment for patients previously considered difficult or impossible to treat via manual catheterization. ## Clinical Evidence Prospective, non-randomized, multi-center, single-arm post-approval study (MAGiC-CHD) required. Study population: minimum 40 adult patients with congenital heart disease and limited access. Primary endpoints: acute procedural success, chronic success at 6 months, and device/procedure-related serious adverse events through 7 days. Follow-up includes 12-lead ECG, Holter, and symptom-driven monitoring. ## Technological Characteristics Catheter for cardiac electrophysiology; utilizes radiofrequency (RF) energy for ablation; requires compatible irrigation pump and robotic magnetic navigation system. Designed for navigation in complex congenital heart disease anatomies. ## Regulatory Identification This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae]. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION January 5, 2026 Stereotaxis, Inc. Angela McKnight Senior Regulatory Affairs Specialist 710 Tucker Blvd., Suite 110 St. Louis, Missouri 63101 Re: P240014 Trade/Device Name: MAGiC Ablation Catheter Product Code: LPB Filed: May 23, 2025 Amended: May 23, 2025; October 7, 2025 Dear Angela McKnight: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 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. Based upon the information submitted, the PMA is approved. You may begin commercial distribution of the device in accordance with the conditions of approval described below. Although this letter refers to your product as a device, please be aware that some approved products may instead be combination products. The Premarket Approval Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm identifies combination product submissions. The sale and distribution of this device are restricted to prescription use in accordance with 21 CFR 801.109 and under section 515(d)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (the act). FDA has determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the device. Your device is therefore a restricted device subject to the requirements in sections 502(q) and (r) of the act, in addition to all other applicable requirements, including those governing the manufacture, distribution, and marketing of devices. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} P240014 - Angela McKnight Page 2 Expiration dating for this device has been established and approved at 18 months. This is to advise you that the protocol you used to establish this expiration dating is considered an approved protocol for the purpose of extending the expiration dating as provided by 21 CFR 814.39(a)(7). Continued approval of the PMA is contingent upon the submission of periodic reports, required under 21 CFR 814.84, at intervals of one year (unless otherwise specified) from the date of approval of the original PMA. This report, identified as "Annual Report" and bearing the applicable PMA reference number, should be submitted to the address below. The Annual Report should indicate the beginning and ending date of the period covered by the report and must include the information required by 21 CFR 814.84. In addition to the above, and in order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, under 21 CFR 814.82(a)(9), the Annual Report must include, separately for each model number (if applicable), the number of devices sold and distributed during the reporting period, including those distributed to distributors. The distribution data will serve as a denominator and provide necessary context for FDA to ascertain the frequency and prevalence of adverse events, as FDA evaluates the continued safety and effectiveness of the device. You must obtain approval of your post-approval study (PAS) protocol(s) within 60 days from the date of this order. Within 30 days of your receipt of this letter, you must submit a PMA supplement that includes a complete protocol of your post-approval study described below. Your PMA supplement should be clearly labeled as a "PMA Post-Approval Study Protocol" as noted below and submitted to the address below. Please reference the PMA number above to facilitate processing. If there are multiple protocols being finalized after PMA approval, please submit each protocol as a separate PMA supplement. In addition to the Annual Report requirements, you must provide the following data in post-approval study (PAS) reports for each PAS listed below. The MAGiC-CHD Post-Approval Study (PAS) is a prospective, non-randomized, multi-center, single-arm study to confirm the effectiveness and safety of the MAGiC Ablation Catheter for the treatment of supraventricular tachycardia (SVT) in adult patients with congenital heart disease (CHD) and limited vascular access or difficult access to the target cardiac chamber. A minimum of 40 adult patients with congenital heart disease will undergo an ablation procedure using the MAGiC Ablation Catheter, a compatible radiofrequency (RF) generator, a compatible irrigation pump, a compatible robotic magnetic navigation system, and related accessories, for the treatment of SVT. Types of SVT will include, but not be limited to, macro-reentrant atrial tachycardia (including cavotricuspid isthmus (CTI)-dependent atrial flutter and non-CTI-dependent atrial flutter) and focal atrial tachycardia. Types of SVT will not include atrial fibrillation. The presence of anatomic abnormalities and/or previous surgical interventions that limit vascular or target chamber access by conventional manual catheter navigation is required for study entrance. All subjects will be enrolled and treated in the United States (US), European Union (EU), or Canada, with the majority enrolled in the US. Follow-up clinical data will be collected at discharge, 7 days, 1 month, and 6 months post-procedure. Arrhythmia monitoring during follow-up includes in-office 12-lead electrocardiogram (ECG) or Holter monitoring and symptom-driven event monitoring. The primary objectives of the PAS will be the following: - Estimating the rate of acute procedural success. {2} P240014 - Angela McKnight Page 3 - Estimating the rate of chronic success through 6 months post-procedure. - Estimating the rate of device- or procedure-related serious adverse events through 7 days post-procedure. Secondary/Additional objectives will include but are not limited to: - Estimating the rate of serious adverse events related to the MAGiC Ablation Catheter. - Estimating acute procedural success and chronic success by type of target arrhythmia and by specific congenital defect and surgical repair. - Evaluating arrhythmia or procedure-related hospitalizations and major adverse events through 6-month follow-up. - Assessing all serious adverse events for severity, relatedness, and outcome. - Estimating fluoroscopy time/dose and procedure time. - Estimating change in patient quality of life and arrhythmia burden. From the date of study protocol approval, you must meet the following timelines for the MAGiC-CHD PAS: - First subject enrolled within 6 months - 20% of subjects enrolled within 12 months - 50% of subjects enrolled within 18 months - 100% of subjects enrolled within 24 months In addition, you must submit separate periodic reports on the progress of the MAGiC-CHD PAS as follows: - PAS Progress Reports every six (6) months until subject enrollment has been completed, and annually thereafter, from the date of the PMA approval letter, unless otherwise specified by FDA. - If any enrollment milestones are not met, you must begin submitting quarterly enrollment status reports every 3 months in addition to your periodic (6-month) PAS Progress Reports, until FDA notifies you otherwise. - Submit the Final PAS Report three (3) months from study completion (i.e., last subject’s last follow-up date). Each PAS report should be submitted to the address below identified as a "PMA Post-Approval Study Report" in accordance with how the study is identified above and bearing the applicable PMA reference number. Be advised that failure to comply with any post-approval requirement, including the enrollment of the specified number of subjects, constitutes grounds for FDA withdrawal of approval of the PMA in accordance with 21 CFR 814.82(c) and 814.46(a)(2). Be advised that the failure to conduct any such study in compliance with the good clinical laboratory practices in 21 CFR part 58 (if a non-clinical study subject to part 58) or the institutional review board regulations in 21 CFR part 56 and the informed consent regulations in 21 CFR part 50 (if a clinical study involving human subjects) may be grounds for FDA withdrawal of approval of the PMA in accordance with 21 CFR 814.46(a)(3)-(4). {3} P240014 - Angela McKnight Page 4 Be advised that protocol information, interim and final results will be published on the Post-Approval Studies Program Database Webpage, available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm. In addition, the results from any post approval study should be included in the labeling as these data become available. Under 21 CFR 814.39, any updated labeling must be submitted to FDA in the form of a PMA Supplement. For more information on post-approval studies, see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order" (https://www.fda.gov/media/71327/download). This is a reminder that as of September 24, 2014, class III devices are subject to certain provisions of the final Unique Device Identification (UDI) rule. These provisions include the requirement to provide a UDI on the device label and packages (21 CFR 801.20), format dates on the device label in accordance with 21 CFR 801.18, and submit data to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). Additionally, 21 CFR 814.84 (b)(4) requires PMA annual reports submitted after September 24, 2014, to identify each device identifier currently in use for the subject device, and the device identifiers for devices that have been discontinued since the previous periodic report. It is not necessary to identify any device identifier discontinued prior to December 23, 2013. Combination Products may also be subject to UDI requirements (see 21 CFR 801.30). For more information on these requirements, please see the UDI website available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-udi-system. Before making any change affecting the safety or effectiveness of the PMA device, you must submit a PMA supplement or an alternate submission (30-day notice) in accordance with 21 CFR 814.39. All PMA supplements and alternate submissions (30-day notice) must comply with the applicable requirements in 21 CFR 814.39. Additional information about changes that may require a PMA supplement are provided in the FDA guidance document entitled, "Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process" https://www.fda.gov/media/81431/download. Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production and process controls (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). You are reminded that many FDA requirements govern the manufacture, distribution, and marketing of devices. For example, in accordance with the Medical Device Reporting (MDR) regulation, 21 CFR 803.50 and 21 CFR 803.52 for devices or post-marketing safety reporting (21 CFR Part 4, Subpart B) for combination products, you are required to report adverse events for this device. Manufacturers of medical devices, including in vitro diagnostic devices, are required to report to FDA no later than 30 calendar days after the day they receive or otherwise becomes aware of information, from any source, that reasonably suggests that one of their marketed devices: 1. May have caused or contributed to a death or serious injury; or {4} P240014 - Angela McKnight Page 5 2. Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Additional information on MDR, including how, when, and where to report, is available at https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems and on combination product post-marketing safety reporting is available at https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products. In accordance with the recall requirements specified in 21 CFR 806.10 for devices or the post-marketing safety reporting requirements (21 CFR Part 4, Subpart B) for combination products, you are required to submit a written report to FDA of any correction or removal of this device initiated by you to: (1) reduce a risk to health posed by the device; or (2) remedy a violation of the act caused by the device which may present a risk to health, with certain exceptions specified in 21 CFR 806.10(a)(2). Additional information on recalls is available at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls. CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. CDRH will notify the public of its decision to approve your PMA by making available, among other information, a summary of the safety and effectiveness data upon which the approval is based. The information can be found at https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals. Written requests for this information can also be made to the Food and Drug Administration, Dockets Management Branch, (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The written request should include the PMA number or docket number. Within 30 days from the date that this information is placed on the Internet, any interested person may seek review of this decision by submitting a petition for review under section 515(g) of the act and requesting either a hearing or review by an independent advisory committee. FDA may, for good cause, extend this 30-day filing period. Failure to comply with any post-approval requirement constitutes a ground for withdrawal of approval of a PMA. The introduction or delivery for introduction into interstate commerce of a device that is not in compliance with its conditions of approval is a violation of law. You are reminded that, as soon as possible and before commercial distribution of your device, you must submit an amendment to this PMA submission with a copy of all final labeling. Final labeling that is identical to the labeling approved in draft form will not routinely be reviewed by FDA staff when accompanied by a cover letter stating that the final labeling is identical to the labeling approved in draft form. If the final labeling is not identical, any changes from the final draft labeling should be highlighted and explained in the amendment. All required documents should be submitted to the CDRH Portal and should reference the above PMA number to facilitate processing. For more information on the CDRH Portal, please visit https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal. {5} P240014 - Angela McKnight Page 6 If you have any questions concerning this approval order, please contact Makarand Deo at Makarand.Deo@fda.hhs.gov. Sincerely, **HETAL B. ODOBASIC -S** Hetal Odobasic Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health --- **Source:** [https://fda.innolitics.com/device/P240014](https://fda.innolitics.com/device/P240014) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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