Five of Canada's six pulsed field ablation licences show a conditional status

Executive summary

Six Class IV licences that hold a pulsed field ablation catheter or system sit on Health Canada's active listing. Five are Issued/Conditional, against a register-wide rate of 0.35 per cent; the sixth, Medtronic's Affera Ablation System, is Issued/Active, and its Regulatory Decision Summary attaches two terms and conditions. A sponsor planning a Canadian PFA launch should expect conditions, on the licence or in its decision summary, and should not expect the licence register to say what they are; for four of the six, the summaries do.

Counts are as at 20 September 2026 unless a sentence gives another date.

Revised 1 October 2026: the line above states the date the counts are as at. No figure, identifier or finding changed.

Health Canada's active licence listing, read on 20 September 2026, contains six Class IV licences that hold a pulsed field ablation catheter or system: five identified by their licence names, Medtronic's PulseSelect (licence 110572), Boston Scientific's Farapulse (111047), Biosense Webster's Varipulse (111495), Abbott's Volt (115142) and Kardium's Globe (115863), and one by its device list and its decision summary, Medtronic's Affera Ablation System (115505), whose Sphere-9 catheter delivers radiofrequency or pulsed field energy. Five carry licence status D, which the MDALL documentation defines as Issued/Conditional. Affera carries status I, Issued/Active, and its Regulatory Decision Summary (RDS17111) attaches two terms and conditions. Two Class III generator licences complete the register's pulsed field holdings, Biosense Webster's TruPulse (111477) and Abbott's Current PFA (115141), both Issued/Active; a supplement on Abbott's Volt PMA carries the trade name "Current PFA Generator  TactiFlex Duo".

Corrected 24 September 2026: this paragraph previously read "contains five Class IV licences whose names identify a pulsed field ablation catheter or system" and "All five carry licence status D"; it called Current PFA "a sixth licence". Licence 115505, the Affera Ablation System, holds the Sphere-9 catheter and the HexaPulse PF generator, and its decision summary states the catheter delivers radiofrequency or pulsed field energy; it is Issued/Active. Licence 111477, the TruPulse generator, is the Class III generator of the Varipulse system. A search of licence names alone missed both.

Conditional status is rare on the register. Of 35,744 licences in the active listing, 124 are conditional, 0.35 per cent. Among the 1,575 Class IV licences, 70 are conditional, 4.44 per cent. Among the 133 licences ArrHub has confirmed as electrophysiology devices, five are conditional: the four pulsed field licences in that set and Abbott's Aveir leadless pacemaker. The 43 other confirmed licences whose names carry "ablation" are Issued/Active; one of them, Affera, delivers pulsed field as well as radiofrequency energy.

Corrected 30 September 2026: two of the six Canadian licences cover the catheter only; 'systems' now reads 'devices'.

The six systems hold FDA premarket approval under product code QZI, the FDA's code for percutaneous cardiac ablation catheters using irreversible electroporation, and each took supplements this year. Between 2 January and 4 September 2026 the FDA recorded 39 supplement decisions on the six PMAs, out of 343 electrophysiology supplement decisions ArrHub holds for that window.

Corrected 24 September 2026: this paragraph previously counted five PMAs and 28 supplement decisions; Affera's P240013 adds 11.

The licence register will not say what the conditions are, when they were imposed, or what would discharge them. The conditions themselves are printed in a different Health Canada record, the Regulatory Decision Summary, for five of the six licences: Volt (RDS16908), Affera (RDS17111), Varipulse (RDS17224), Globe (RDS17357) and Farapulse (RDS17456). For Farapulse, an earlier summary of the same amendment, RDS17368, states that the terms and conditions issued before 1 January 2026 continue to apply, without listing them; both remain on the register. PulseSelect's three summaries print none. Section 4 transcribes each.

Corrected 30 September 2026: Health Canada published a second summary of Farapulse's August amendment, RDS17456, which prints four conditions; sixteen summaries now name one of the six licences.

Revised 30 September 2026: one sentence removed because it read as advice to the reader.

Corrected 24 September 2026: this paragraph previously read "for three of the five licences"; Affera's RDS17111 is the fourth summary that prints conditions.

Corrected 24 September 2026: this paragraph previously ended "That information exists only in the sponsor's own licence correspondence". Health Canada publishes the terms and conditions in its Regulatory Decision Summaries for three of the five licences, and refers to them for a fourth.

1. The licences

Five of the six pulsed field ablation catheters or systems on Health Canada's active licence listing hold status D; Affera holds status I. Table 1 lists the six Class IV licences that hold a pulsed field ablation catheter or system and the two Class III generator licences, as the register spells them; Affera's licence name does not say pulsed field, its device list and its decision summary do.

The two generator licences, Abbott's Current PFA (115141) and Biosense Webster's TruPulse (111477), name no catheter; both are active. Affera's device list holds the SPHERE-9 CATHETER, the HEXAPULSE PF GENERATOR and the HEXAGEN RF GENERATOR, and its decision summary states that the catheter delivers radiofrequency or pulsed field energy.

Corrected 22 September 2026: the headline previously read 'catheter and system'. Licence 115141 is a system with an active licence.

Corrected 24 September 2026: Table 1 previously listed five Class IV licences and one Class III licence, and this paragraph read "Abbott's Current PFA (licence 115141) is a generator system with no catheter; its licence is active." Licence 115505, the Affera Ablation System, holds a catheter that delivers pulsed field energy and is Issued/Active; licence 111477, the TruPulse generator, is the Class III generator of the Varipulse system. Both were missed by a search of licence names alone.

Status D is defined in the MDALL documentation as Issued/Conditional and status I as Issued/Active. All eight records carry a null end date. FDA supplement P250022/S005, on Abbott's Volt PMA, carries the trade name "Current PFA Generator  TactiFlex Duo", and "CURRENT PFA GENERATOR" is a device name under licence 115141; the Varipulse summaries name the TruPulse generator as MDL 111477. The generator licences are included in Table 1 so that the register's complete pulsed field ablation holdings are visible.

The five conditional licences span thirty-one months of issue dates, from 13 December 2023 to 29 July 2026 (Figure 1). The status has not converged towards Issued/Active with time: the oldest of the five, PulseSelect, has been conditional for the whole period the register shows.

2. The base rate

Conditional status is unusual on the register and pulsed field ablation is an outlier within it. Table 2 gives the rate by risk class for the whole active listing.

Within electrophysiology the contrast is sharper. ArrHub has confirmed 133 licences on the register as electrophysiology devices (the scope is set out in the methodology). Of those, 128 are Issued/Active and five are Issued/Conditional. The five are the four pulsed field ablation licences that fall inside the confirmed set (PulseSelect, Farapulse, Varipulse and Globe) and Abbott's Aveir leadless pacemaker, licence 107649, conditional since 22 April 2022. Abbott's Volt catheter lies outside the confirmed set for a reason explained in the methodology, which is why the confirmed count is four and the register count is five.

Corrected 30 September 2026: two of the six Canadian licences cover the catheter only; 'systems' now reads 'devices'.

Corrected 24 September 2026: Table 3 previously counted four pulsed field ablation licences in the confirmed set, all conditional. The Affera Ablation System (115505) is in the confirmed set and is Issued/Active.

No radiofrequency or cryoablation licence in the confirmed set is conditional. Forty-six confirmed licences carry "ablation" in their licence names: three of the pulsed field devices (PulseSelect, Farapulse and Varipulse), Medtronic's Affera Ablation System, which delivers radiofrequency or pulsed field energy, and 42 radiofrequency and cryoablation catheters, consoles and cables from Abbott, AtriCure, Biosense Webster, Boston Scientific, Medtronic and St. Jude Medical; the 43 other than the three pulsed field licences are Issued/Active. Kardium's Globe is named "GLOBE PULSED FIELD SYSTEM". Within the confirmed set, conditional status attaches to four pulsed field ablation licences and to one leadless pacemaker, and to nothing else.

Corrected 30 September 2026: two of the six Canadian licences cover the catheter only; 'systems' now reads 'devices'.

Corrected 24 September 2026: this paragraph previously counted the 43 as "radiofrequency and cryoablation catheters, consoles and cables"; one of them, the Affera Ablation System, delivers pulsed field energy as well.

Corrected 22 September 2026: this paragraph previously read "Forty-seven confirmed licences carry "ablation" in their names; four are the pulsed field systems above". Counted by licence name the figure is 46; Globe's licence name does not contain "ablation".

3. The US side

Each of the six systems holds an FDA premarket approval under product code QZI, and each PMA took supplements during the ingested window. Table 4 counts the supplement decisions the FDA published between 2 January and 4 September 2026, by PMA and supplement type, with the applicant as the FDA record names it.

Corrected 24 September 2026: Table 4 previously counted five PMAs and 28 decisions; Affera's P240013 adds 11.

The 39 decisions are 11.4 per cent of the 343 electrophysiology PMA supplement decisions ArrHub recorded in the window, spread across 69 PMAs. Farapulse, Inc. is the applicant of record for P230030; Boston Scientific acquired Farapulse in 2021, and the two are treated as one organisation throughout this document.

4. What the register does and does not say

The register says that a licence exists, what it is called, who holds it, its risk class, its status as a one-letter code, the date of its first status and whether it has ended. For the five licences in Table 1 that is the complete public record: status D, defined by the MDALL documentation as Issued/Conditional, first licence status dates from 2023 to 2026, no end date, and a last refresh by Health Canada on 18 September 2026.

The register does not say what the conditions are. No field in the licence record carries condition text, a reference to a condition letter, the date a condition was imposed, or the date one was discharged. It does not say whether a licence has ever changed status, because it publishes the current status and the date of the first status, nothing more. It does not say what would move a licence from D to I, or whether any of the six is under review.

Another Health Canada record carries part of what the licence register does not. Health Canada publishes a Regulatory Decision Summary for the applications the Medical Devices Bureau decides, and sixteen summaries name one of the six licences: three for PulseSelect (RDS14608, RDS14864 and RDS16489), five for Farapulse (RDS14470, RDS13724, RDS16112, RDS17368 and RDS17456), four for Varipulse (RDS13262, RDS15890, RDS16103 and RDS17224), one for Volt (RDS16908), two for Affera (RDS17111 and RDS17403) and one for Globe (RDS17357). Each summary names the licence number it issued or amended. Six are typed "with conditions", and all six are decisions dated 2026: the new licences for Volt (2 April 2026), Affera (3 June 2026) and Globe (29 July 2026), and amendments to Varipulse (13 July 2026) and Farapulse (18 August 2026, two summaries of one application). The ten earlier summaries, dated December 2023 to December 2025, are typed "New device licence application" or "Amendment device licence application" and print no terms and conditions, while the register shows status D for five of the six licences and status I for Affera (Table 1). Table 5 transcribes the terms and conditions as the summaries print them; PulseSelect's summaries print none.

Corrected 30 September 2026: Health Canada published a second summary of Farapulse's August amendment, RDS17456, which prints four conditions; sixteen summaries now name one of the six licences.

Corrected 24 September 2026: this paragraph previously counted thirteen summaries for five licences, four typed with conditions. Affera's RDS17111 and RDS17403 were added.

The MDALL documentation defines eleven status codes: C (Cancelled), D (Issued/Conditional), I (Issued/Active), M (Merge), O (Discontinued at Renewal), P (Pending signature), Q (Suspended/Invalid QS Certification), R (Cancelled Renowal No Response, as spelled on the MDALL page), S (Suspended), W (Withdrawn) and X (Cancelled QS/2003). The active listing this document reads contains only two of them, I and D. A licence that leaves the active listing leaves this dataset, so the register as read here cannot show a pulsed field ablation licence being cancelled, suspended or withdrawn. The conditions are printed in Table 5 as the summaries print them; nothing in this document should be read as a statement about the reasons Health Canada attached them, or about whether any has been discharged.

Corrected 24 September 2026: this paragraph previously ended "Nothing in this document should be read as a statement about what the conditions on any licence are, or about the reasons Health Canada attached them". The conditions are published for three of the five licences and are now transcribed in Table 5.

Methodology

Sources

Health Canada Medical Devices Active Licence Listing (MDALL), read through its public API at health-products.canada.ca/api/medical-devices. The licence endpoint with state=active returned 35,744 licence records, and the company endpoint 7,653 company records, on 20 September 2026 at 02:17 UTC. Each licence record reports a last refresh date of 18 September 2026. The MDALL API documentation supplies the status code definitions used throughout.

openFDA device/pma, from which ArrHub ingests premarket approval supplement decisions for electrophysiology product codes. The verified registry held 343 supplement decisions on 69 PMAs dated between 2 January and 4 September 2026 when this document was written. The US figures in this document come from that registry; the FDA PMA database at accessdata.fda.gov served to verify records, not as a source of facts.

Health Canada Regulatory Decision Summaries for medical devices, read through the Drug and Health Product Register API at health-products.canada.ca/api/dhpr on 24 September 2026. The register's list was searched by product name for each of the six licences, and each summary's detail record was read for the licence number it names, its application type, its decision date and the terms and conditions it prints. The summaries' pages on the Drug and Health Products Portal answered "Page not found" for these records on that date; the API record is the record cited.

Health Canada publishes the licence listing and the Regulatory Decision Summaries under the Open Government Licence – Canada. Contains information licensed under the Open Government Licence – Canada.

Field-level verification

The six Canadian licences read on 20 September 2026 (110572, 111047, 111495, 115142, 115863 and 115141) were re-read from their MDALL API records after the registry extract and compared field by field: licence number, licence name, status code, risk class, first licence status date and end date; all six matched the registry on every field. Licences 115505 and 111477 were read from their MDALL API records and device lists on 24 September 2026. Each FDA PMA cited was opened at accessdata.fda.gov on the day it was read; the applicant, trade name and supplement numbers on the FDA page matched the supplements held in the registry for the window. Each licence number and PMA number in a source line links to the agency record it was verified against. Each Regulatory Decision Summary cited was read from the register API on 24 September 2026, and RDS17456 on 30 September 2026; the licence number and application type of the sixteen, and the terms and conditions printed in Table 5, are compared word for word against the summary records by the citation gate before this document is published.

Names are printed as the registers spell them, with one display-time correction. openFDA publishes some trade names with C1 control characters (U+0080 to U+009F) where the FDA's own record shows a typographic symbol; U+0099 stands where the record shows ™. Those characters are displayed as the Windows-1252 symbols they represent. The stored data is not altered, and no other character is touched. The system names in Table 4 are shortened forms, so the correction does not touch them.

Organisation resolution

Applicants and licence holders are matched to organisations through ArrHub's verified alias table, and the raw names are kept as the registers spell them. Five aliases bear on this document. Farapulse, Inc. resolves to Boston Scientific: Boston Scientific's 10-K for 2021 states that it completed the acquisition of Farapulse, Inc. in the third quarter of 2021. Biosense Webster, Inc. resolves to Johnson & Johnson: Johnson & Johnson's 10-K for 1997 lists Biosense, Inc. among its 1997 mergers, and exhibit 21 of its 10-K for 2025 lists Biosense Webster, Inc. among its subsidiaries. ABBOTT MEDICAL resolves to Abbott, and Medtronic, Inc. and Kardium, Inc. resolve to Medtronic and Kardium, by name normalisation. Each alias carries a verified flag and the name of the person or rule that set it.

Scope

The confirmed electrophysiology set is the 133 licences on the active listing that ArrHub had confirmed as electrophysiology devices as at 20 September 2026. A licence enters the candidate pool when its English licence name contains one of the keywords held in ArrHub's controlled vocabulary; at extraction there were fourteen (ablation, arrhythm, cardioverter, cryoablation, defibrillator, electrophysiol, holter, intracardiac, leadless, loop recorder, mapping, pacemaker, pulsed field, resynchron), and a fifteenth, "PFA catheter", was added afterwards for the reason given under Limitations. The pool held 250 candidates at extraction. Membership of the confirmed set was then decided per licence, either by a human reviewing a proposal or by a deterministic rule matching a known electrophysiology manufacturer and a cardiac keyword; each confirmed record carries the keyword that made it a candidate. The method of confirmation is recorded in the database from 24 September 2026. For 62 of the 133 licences confirmed by 20 September, a review file in the ArrHub repository records that a language model proposed them and a person confirmed them; for the other 71, no record of the method was kept.

Corrected 24 September 2026: this paragraph previously read "each confirmed record carries the method that confirmed it".

The pulsed field ablation set in Table 1 was not taken from the confirmed set. It comes from a search of the 35,744 licence names and their 155,847 active device names for "pulsed field", "PFA", "PF", "electroporation", "irreversible" and the known product names, and from a search of the text of the Regulatory Decision Summaries published since 2022 for "pulsed field", "electroporation" and "PFA", so that the finding rests on the whole register and not on the reviewed subset.

Corrected 24 September 2026: this search previously covered licence names alone, and missed licence 115505, whose licence name is AFFERA ABLATION SYSTEM, and licence 111477, TRUPULSE GENERATOR.

Limitations

At the extraction of 20 September 2026 the pool held 250 candidates, of which 133 were confirmed and 117 unreviewed. The register was re-ingested later the same day with the extended keyword set described below; the pool now holds 256 candidates, 133 confirmed, four rejected and 119 unreviewed as at the re-ingestion date. The counts in Table 3 will change as review continues. The unreviewed candidates cannot change the finding in Table 1, which comes from the whole register, but they can change the confirmed-set ratio in Table 3.

The keyword rule in force at extraction missed one pulsed field ablation licence. Abbott's Volt catheter, licence 115142, is named "VOLT PFA CATHETER, SENSOR ENABLED"; the abbreviation PFA was not among the fourteen keywords, so at the time of extraction on 20 September the licence was outside the candidate pool and is not in the confirmed set. It was found by the whole-register name search and is included in Table 1 on that basis. The keyword set has since been extended with "PFA catheter", which brings the Volt licence into the pool as an unreviewed candidate; the bare term "PFA" was tried before it and withdrawn after it matched four Siemens platelet function analyser licences.

A search of licence names alone also missed the Affera Ablation System (115505), whose name does not say pulsed field: its device list holds the SPHERE-9 CATHETER and the HEXAPULSE PF GENERATOR, and its decision summary states that the catheter delivers radiofrequency or pulsed field energy. It missed the TruPulse generator (111477) for the same reason. The register's device names and the summaries' text are now searched as well. A search of licence names for "electroporation" finds none; among device names it finds two aesthetic handpieces under Class II licences and no ablation device. Summaries for four mapping and monitoring systems mention pulsed field ablation or PFA for compatibility (CARTO 3, RHYTHMIA HDX, Ivy Biomedical's Cardiac Trigger Monitor and the Affera Integrated Mapping System); they deliver no ablation energy and are not in Table 1.

Corrected 24 September 2026: the previous paragraph read "Any pulsed field ablation licence whose name contains neither 'pulsed field', 'PFA' nor one of the five product names would be missed by the same search; none was found by a search for 'electroporation'". Two such licences existed.

Exclusions

Four Class II licences held by Siemens Healthcare Diagnostics Products GmbH whose names contain "PFA" (PFA-100, INNOVANCE PFA-200, INNOVANCE PFA P2Y and DADE PFA REAGENTS) are excluded from Table 1. They are in vitro diagnostics licences, not ablation devices, and all four are Issued/Active. Licence 106121, Abbott's EnSite X EP System, lists a "PFA generator connect cable" among its devices, and licence 115643, Medtronic's Affera Integrated Mapping System, is the mapping system that accompanies the Affera Ablation System; neither delivers ablation energy, and neither is in Table 1.

The archived MDALL listing, which holds licences no longer active, was not read. Health Canada Class I devices, which are not licensed, are outside the register.

Not covered

The licence register does not publish the conditions attached to a conditional licence, the correspondence that set them, or any history of status changes. The Regulatory Decision Summaries transcribed in Table 5 print the terms and conditions for five of the six licences, and for Farapulse an earlier summary of the same amendment refers to earlier ones without listing them; this document says nothing about why they were attached, whether the unprinted ones differ, or whether any has been discharged. Commercial availability in Canada is not a register fact and is not addressed.

Corrected 30 September 2026: Health Canada published a second summary of Farapulse's August amendment, RDS17456, which prints four conditions; sixteen summaries now name one of the six licences.

Corrected 24 September 2026: this paragraph previously read "This document therefore makes no statement about what the conditions are, why they were attached, whether they differ between the five licences, or whether any has been discharged".

About the editor

ArrHub is edited by a Toronto-based intellectual property and technology lawyer with thirty years in patent licensing and technology law, who built the ingestion and verification pipeline that produces these records from public regulatory registers. ArrHub is published in Montreal and Toronto.