AFFERA ABLATION SYSTEM

Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status I, which the register defines as Issued/Active. First issued 3 June 2026.

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	115505	original_licence_no
Licence status	I (Issued/Active)	licence_status
Application risk class	4	appl_risk_class
Licence name	AFFERA ABLATION SYSTEM	licence_name
Licence name, French	AFFERA ABLATION SYSTEM	licence_name_fr
Date of the first issued licence	2026-06-03	first_licence_status_dt
Date of cancellation	null	end_date
Licence type	System	licence_type_desc
Company identification number	114663	company_id

Source: Health Canada MDALL, licence 115505, 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.

MEDTRONIC INC.

710 Medtronic Parkway N.E.
Minneapolis MN 55432, 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 115505, 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
1085808JSON	SPHERE-9 CATHETER	2026-06-03	null
1085812JSON	HEXAPULSE PF GENERATOR	2026-06-03	null
1085813JSON	HEXAGEN RF GENERATOR	2026-06-03	null
1085814JSON	HEXAFLOW IRRIGATION PUMP	2026-06-03	null
1085815JSON	CATHETER EXTENSION CABLE	2026-06-03	null
1085816JSON	TUBING SET	2026-06-03	null

Source: Health Canada MDALL, device records for licence 115505, 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.

RDS17403JSON

Amendment device licence application, application 413526

Decision date 2026-08-26. Filed 2026-06-19.

Prints no terms and conditions.

RDS17111JSON

New device licence application with conditions, application 400253

Decision date 2026-06-03. Filed 2025-10-22.

Prints 2 terms and conditions:

PROVIDE UPDATES ON CLINICAL OUTCOMES FROM ON-GOING CLINICAL TRIALS AND POST-MARKET MONITORING OF THE DEVICE.
PROVIDE ADDITIONAL ANALYSIS FOR ESTIMATED RATES OF RARE ADVERSE EVENTS, LONG-TERM DURABILITY OF ABLATION TREATMENT, AND OUTCOMES IN UNDER-REPRESENTED PATIENT POPULATIONS.

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

P240013

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

587

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=115505&lang=en&type=json

{
  "original_licence_no": 115505,
  "licence_status": "I",
  "licence_status_desc": "Issued/Active",
  "appl_risk_class": 4,
  "licence_name": "AFFERA ABLATION SYSTEM",
  "licence_name_fr": "AFFERA ABLATION SYSTEM",
  "first_licence_status_dt": "2026-06-03",
  "end_date": null,
  "licence_type_desc": "System",
  "company_id": 114663,
  "company_name": "MEDTRONIC INC.",
  "country_cd": "US",
  "city": "Minneapolis",
  "source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=115505&lang=en&type=json",
  "verified_at": "2026-09-20T02:17:28.537809+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=115505&type=active&lang=eng",
  "company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=114663&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.