VOLT PFA CATHETER, SENSOR ENABLED

Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status D, which the register defines as Issued/Conditional. First issued 1 April 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	115142	original_licence_no
Licence status	D (Issued/Conditional)	licence_status
Application risk class	4	appl_risk_class
Licence name	VOLT PFA CATHETER, SENSOR ENABLED	licence_name
Licence name, French	VOLT PFA CATHETER, SENSOR ENABLED	licence_name_fr
Date of the first issued licence	2026-04-01	first_licence_status_dt
Date of cancellation	null	end_date
Licence type	Device Group	licence_type_desc
Company identification number	112010	company_id

Source: Health Canada MDALL, licence 115142, 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.

ABBOTT MEDICAL

5050 Nathan Lane North
Plymouth MN 55442, US

Company status A

All licences held by this companyCompany record on Health Canada

Resolved to

Abbott

The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:prefix. Source: fda_applicant. Verified 20 September 2026.

Devices on this licence

Each device the register lists under licence 115142, 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
1064785JSON	VOLT PFA CATHETER, SENSOR ENABLED	2026-04-01	null

Source: Health Canada MDALL, device records for licence 115142, 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.

RDS16908JSON

New device licence application with conditions, application 403387

Decision date 2026-04-02. Filed 2025-10-30.

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, 24 September 2026.

FDA record pair

P250022

PMA original, product code QZI. FDA decision 19 December 2025. Pair confirmed under the verification protocol by product name, human review, 24 September 2026; reference class pfa_system.

103

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=115142&lang=en&type=json

{
  "original_licence_no": 115142,
  "licence_status": "D",
  "licence_status_desc": "Issued/Conditional",
  "appl_risk_class": 4,
  "licence_name": "VOLT PFA CATHETER, SENSOR ENABLED",
  "licence_name_fr": "VOLT PFA CATHETER, SENSOR ENABLED",
  "first_licence_status_dt": "2026-04-01",
  "end_date": null,
  "licence_type_desc": "Device Group",
  "company_id": 112010,
  "company_name": "ABBOTT MEDICAL",
  "country_cd": "US",
  "city": "Plymouth",
  "source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=115142&lang=en&type=json",
  "verified_at": "2026-09-20T02:17:29.146298+00:00",
  "ep_confirmed_at": "2026-09-24T03:05:34.247724+00:00",
  "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=115142&type=active&lang=eng",
  "company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=112010&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.