Health Canada licence record

Licence 111047

FARAPULSE PULSED FIELD ABLATION SYSTEM

Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status D, which the register defines as Issued/Conditional. First issued 4 April 2024.

Open on Health CanadaAgency recordJSON

Licence

Each row is one field of the agency record. The grey name beside the label is the field’s name in the agency’s own documentation.

Field	Value	Field name
Licence number	111047	original_licence_no
Licence status	D (Issued/Conditional)	licence_status
Application risk class	4	appl_risk_class
Licence name	FARAPULSE PULSED FIELD ABLATION SYSTEM	licence_name
Licence name, French	FARAPULSE PULSED FIELD ABLATION SYSTEM	licence_name_fr
Date of the first issued licence	2024-04-04	first_licence_status_dt
Date of cancellation	null	end_date
Licence type	System	licence_type_desc
Company identification number	139858	company_id

Source: Health Canada MDALL, licence 111047, API record retrieved 2026-10-10 22:15 Eastern. Status codes as defined in the MDALL API guide.

Company

The licence holder as the register records it. The company page lists every licence under this identification number.

BOSTON SCIENTIFIC CORPORATION

300 Boston Scientific Way
Marlborough MA 01752, US

Company status A

All licences held by this companyCompany record on Health Canada

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

Devices on this licence

Each device the register lists under licence 111047, with the date it was added. Later additions do not change the date of the first issued licence.

Device ID	Trade name	Added to licence	Removed
1060197JSON	FARAWAVE PULSED FIELD ABLATION CATHETER	2024-04-04	null
1060198JSON	FARADRIVE STEERABLE SHEATH	2024-04-04	null
1060199JSON	FARASTAR CATHETER CONNECTION CABLE	2024-04-04	null
1060200JSON	FARASTAR PULSED FIELD ABLATION GENERATOR	2024-04-04	null
1060201JSON	FARASTAR PULSED FIELD ABLATION GENERATOR AND COMPONENTS	2024-04-04	null
1060202JSON	FARASTAR RECORDING SYSTEM MODULE	2024-04-04	null
1060203JSON	FARASTAR RECORDING SYSTEM MODULE AND COMPONENTS	2024-04-04	null
1060204JSON	FARASTAR STIMULATION MODULE CABLE	2024-04-04	null
1060205JSON	FARASTAR EGM CABLE	2024-04-04	null
1060206JSON	FARASTAR STIMULATION MODULE MALE CABLE	2024-04-04	null
1060207JSON	FARASTAR STIMULATION MODULE FEMALE CABLE	2024-04-04	null
1060208JSON	FARASTAR STIMULATION MODULE Y-CABLE	2024-04-04	null
1060209JSON	FARASTAR RECORDING SYSTEM MODULE CATHETER PIN CABLE	2024-04-04	null
1060210JSON	FARASTAR RECORDING SYSTEM MODULE ECG TRUNK CABLE	2024-04-04	null
1060211JSON	FARASTAR RECORDING SYSTEM MODULE ECG OUTPUT MODULE	2024-04-04	null
1060212JSON	FARASTAR RECORDING SYSTEM MODULE EGM INPUT MODULE	2024-04-04	null
1068009JSON	FARAWAVE NAV PULSED FIELD ABLATION CATHETER	2024-09-19	null
1068010JSON	FARASTAR MAPPING SYSTEM MODULE	2024-09-19	null
1068013JSON	FARASTAR MAPPING SYSTEM MODULE BACK PATCH CABLE	2024-09-19	null
1068014JSON	FARASTAR MAPPING SYSTEM MODULE BACK PATCH CABLE MALE	2024-09-19	null
1068015JSON	FARASTAR MAPPING SYSTEM MODULE BNC-PHONO CABLE	2024-09-19	null
1068017JSON	FARASTAR MAPPING SYSTEM MODULE AUXILIARY CABLE	2024-09-19	null
1086363JSON	FARASTAR INTER-CONNECTION BOX	2025-12-05	null
1086364JSON	FARASTAR RECORDING SYSTEM MODULE ECG OUTPUT TO SIGNAL STATION ECG INPUT CABLE, FARASTAR TO OPAL HDX	2025-12-05	null
1086365JSON	FARASTAR RECORDING SYSTEM MODULE EGM OUTPUT TO SINGAL STATION EGM INPUT CABLE, FARASTAR TO OPAL HDX	2025-12-05	null
1086367JSON	FARASTAR MAPPING SYSTEM MODULE ABL OUTPUT TO SIGNAL STATION ABL INPUT CABLE, FARASTAR TO OPAL HDX	2025-12-05	null
1089247JSON	FARAPOINT BIDIRECTIONAL / F-F CURVE PULSED FIELD ABLATION CATHETER	2026-08-18	null
1089248JSON	FARAPOINT BIDIRECTIONAL / D-F CURVE PULSED FIELD ABLATION CATHETER	2026-08-18	null
1089249JSON	FARASTAR EGM TO EP RECORDING SYSTEM CABLE (FARAPOINT)	2026-08-18	null

Source: Health Canada MDALL, device records for licence 111047, retrieved 2026-10-10 22:15 Eastern. Device identifiers link to the agency’s device record.

Decision summaries

Regulatory Decision Summaries Health Canada has published for this licence, newest first. Each links to the agency’s record.

RDS17456JSON

Amendment device licence application with conditions, application 407670

Decision date 2026-08-18. Filed 2026-01-21.

Prints 4 terms and conditions:

PROVIDE UPDATES ON CLINICAL OUTCOMES FROM ON-GOING DEVICE-SPECIFIC CLINICAL TRIALS AND REGISTRIES.
PROVIDE UPDATES RELATED TO DEVICE SALES AND REPORTED EVENTS.
PROVIDE UPDATES RELATED TO POST-MARKET SAFETY MONITORING OF THE DEVICE.
DRAWING FROM THE SOURCES IDENTIFIED ABOVE, PROVIDE AN ANALYSIS OF SAFETY IN LESS REPRESENTED POPULATIONS AND THE INCIDENCE RATES OF RARE ADVERSE EVENTS.

RDS17368JSON

Amendment device licence application with conditions, application 407670

Decision date 2026-08-18. Filed 2026-01-21.

Prints no terms and conditions.

RDS16112JSON

Amendment device licence application, application 391488

Decision date 2025-07-30. Filed 2025-02-06.

Prints no terms and conditions.

RDS13724JSON

Amendment device licence application, application 379951

Decision date 2024-09-19. Filed 2024-06-17.

Prints no terms and conditions.

RDS14470JSON

New device licence application, application 369626

Decision date 2024-04-04. Filed 2023-11-09.

Prints no terms and conditions.

Source: Health Canada, Drug and Health Product Register, Regulatory Decision Summaries, retrieved 2026-10-10 22:15 Eastern. Terms and conditions as the summary prints them.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

Electrophysiology

Confirmed by review, before 24 September 2026; the review record carries no timestamp.

FDA record pair

P230030

PMA original, product code QZI. FDA decision 30 January 2024. Pair confirmed under the verification protocol by product name, human review, 24 September 2026; reference class pfa_system.

Days from the FDA decision to the first issued Canadian licence. Computed from the two dates.

First seen by ArrHub’s weekly snapshot: 2026-09-20 09:05 Eastern.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)api/medical-devices/licence/?id=111047&lang=en&type=json

{
  "original_licence_no": 111047,
  "licence_status": "D",
  "licence_status_desc": "Issued/Conditional",
  "appl_risk_class": 4,
  "licence_name": "FARAPULSE PULSED FIELD ABLATION SYSTEM",
  "licence_name_fr": "FARAPULSE PULSED FIELD ABLATION SYSTEM",
  "first_licence_status_dt": "2024-04-04",
  "end_date": null,
  "licence_type_desc": "System",
  "company_id": 139858,
  "company_name": "BOSTON SCIENTIFIC CORPORATION",
  "country_cd": "US",
  "city": "Marlborough",
  "source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=111047&lang=en&type=json",
  "verified_at": "2026-09-20T02:17:27.413259+00:00",
  "ep_confirmed_at": null,
  "collected_at": "2026-10-11T02:15:33.877+00:00",
  "last_checked_at": "2026-10-11T02:15:33.877+00:00",
  "record_url": "https://health-products.canada.ca/mdall-limh/information?licenceId=111047&type=active&lang=eng",
  "company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=139858&lang=eng"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at health-products.canada.ca governs where they differ.

Contains information licensed under the Open Government Licence – Canada.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

Report a broken link or a record that does not match its source: alerts@arrhub.com. Corrections are published, with their date, at arrhub.com/corrections.