← Product Code QZI · P250022 # Volt™ PFA System (P250022) _ABBOTT MEDICAL · QZI · Dec 19, 2025 · Cardiovascular · APPR_ **Canonical URL:** https://fda.innolitics.com/device/P250022 ## Device Facts - **Applicant:** ABBOTT MEDICAL - **Product Code:** QZI - **Decision Date:** Dec 19, 2025 - **Decision:** APPR - **Device Class:** Class 3 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use The Volt™ PFA Catheter, Sensor Enabled™ is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal or persistent (episode duration less than one year) atrial fibrillation when used in conjunction with a compatible pulsed field ablation (PFA) generator. The catheter is compatible with the EnSite™ X EP System. The Current™ PFA Generator is indicated for use with compatible ablation catheters for the treatment of cardiac arrhythmias. ## Device Story Volt™ PFA System treats cardiac arrhythmias via pulsed field ablation (PFA); utilizes Volt™ PFA Catheter, Sensor Enabled™ and Current™ PFA Generator; compatible with EnSite™ X EP System for navigation/mapping. Physician-operated in clinical/electrophysiology lab settings. System delivers pulsed electric fields to cardiac tissue to create lesions; intended to restore normal heart rhythm by isolating pulmonary veins. Output includes procedural metrics (fluoroscopy, ICE guidance, sedation) and lesion durability data. Benefits include treatment of drug-refractory atrial fibrillation. Clinical decision-making supported by real-time catheter visualization and procedural success confirmation (entrance/exit block). ## Clinical Evidence PMA approval based on prospective, multi-center, non-randomized, observational post-approval study (PAS) design. Study involves 150 adult patients with paroxysmal or persistent AF. Primary endpoints: rate of device/procedure-related serious adverse events (SAEs) within 7 days; acute procedural success (pulmonary vein entrance block confirmation); freedom from AF/AFL/AT recurrence >30 seconds through 12 months post-procedure (post-90-day blanking). Secondary endpoints include procedural metrics, repeat ablation rates, and lesion durability. ## Technological Characteristics System comprises a sensor-enabled PFA catheter and a PFA generator. Integrates with EnSite™ X EP System for electroanatomical mapping and navigation. Energy source: pulsed field ablation. Connectivity: compatible with existing EP lab mapping systems. Sterilization: device-specific requirements apply. ## Regulatory Identification For the treatment of atrial fibrillation. ## Reference Devices - EnSite™ X EP System ## 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 December 19, 2025 Abbott Medical Alyssa Timmers Principal Regulatory Affairs Specialist One St. Jude Medical Dr. St. Paul, Minnesota 55117 Re: P250022 Trade/Device Name: Volt™ PFA System Product Code: QZI Filed: June 27, 2025 Amended: October 23, 2025 Dear Alyssa Timmers: 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 Volt™ PFA System. This device is indicated for: The Volt™ PFA Catheter, Sensor Enabled™ is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal or persistent (episode duration less than one year) atrial fibrillation when used in conjunction with a compatible pulsed field ablation (PFA) generator. The catheter is compatible with the EnSite™ X EP System. The Current™ PFA Generator is indicated for use with compatible ablation catheters for the treatment of cardiac arrhythmias. 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). The device is further restricted under section 515(d)(1)(B)(ii) of the act insofar as the labeling must specify the specific training or experience practitioners need in order to use the device. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} P250022 - Alyssa Timmers Page 2 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. Expiration dating for this device has been established and approved at six 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. 1. The VOLT Post-Approval Study (PAS) is a prospective, multi-center, non-randomized, observational study to evaluate the long-term effectiveness and safety of the Volt™ PFA System for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PersAF). Up to 150 adult patients who intend to undergo their ablation procedure using the Volt™ PFA System to treat symptomatic, recurrent paroxysmal or persistent atrial fibrillation refractory, intolerant, or contraindicated to at least one Class I-IV antiarrhythmic medication will be enrolled and ablated using the Volt™ PFA System. The study will enroll patients at up to 20 clinical sites in the United States, with at least 50% of patients being women. Following consent, all study subjects will complete a pre-procedure (baseline) visit, ablation procedure, and be followed through 36 months post-ablation. {2} P250022 - Alyssa Timmers Page 3 Follow-up visits will be conducted at discharge, 10-12 weeks, 6-, 12-, 24-, and 36-months post-ablation. Continuous 24-hour rhythm monitoring will be collected at the 12-month, 24-month, and 36-month study visits per site standard of care. The primary objectives of the PAS will be the following: - Estimating the rate of device- and/or procedure-related serious adverse events (SAEs) within 7 days of any ablation procedure using the Volt™ PFA System. - Estimating acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins, with a secondary method of confirmation for all targeted pulmonary veins of one of the following: 20-minute wait following initial pulmonary vein isolation (PVI), followed by a second confirmation of entrance block in each pulmonary vein; or exit block using a multipolar catheter; or isoproterenol or adenosine challenge. - Estimating freedom from documented atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence >30 seconds through 12 months post-procedure (assessed after a 90-day blanking period). Secondary/Additional objectives will include but are not limited to: - Characterizing workflow-specific procedural metrics, including but not limited to fluoroscopy use, intracardiac echocardiography (ICE) guidance, and sedation type. - Analyzing subjects undergoing de novo versus redo procedures separately. - Estimating repeat ablation rates and characterizing lesion durability. - Monitoring hemolysis and renal function per site standard of care. - Characterizing arrhythmia monitoring per site standard of care. PAS Progress Reports must be submitted every six (6) months for the first year and annually thereafter, from the date of the PMA approval letter, unless otherwise specified by FDA. The Final PAS Report should be submitted no later than three (3) months after study completion (i.e., last subject's last follow-up date). From the date of study protocol approval, you must meet the following timelines for the VOLT Post-Approval Study (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 VOLT Post-Approval Study (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. {3} P250022 - Alyssa Timmers Page 4 - 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 enrollment of the complete cohort, 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). 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. {4} P250022 - Alyssa Timmers Page 5 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 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. {5} P250022 - Alyssa Timmers Page 6 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. If you have any questions concerning this approval order, please contact Samson Huang at Samson.Huang@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/P250022](https://fda.innolitics.com/device/P250022) **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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