Health Canada licence record
Licence 111495
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status D, which the register defines as Issued/Conditional. First issued 11 July 2024.
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 | 111495 | original_licence_no |
| Licence status | D (Issued/Conditional) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | VARIPULSE BI-DIRECTIONAL ABLATION CATHETER | licence_name |
| Licence name, French | VARIPULSE BI-DIRECTIONAL ABLATION CATHETER | licence_name_fr |
| Date of the first issued licence | 2024-07-11 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | Single Device | licence_type_desc |
| Company identification number | 160433 | company_id |
Source: Health Canada MDALL, licence 111495, API record retrieved 2026-10-10 22:15 Eastern. Status codes as defined in the MDALL API guide.
The licence holder as the register records it. The company page lists every licence under this identification number.
BIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine CA 92618, US
Company status A
Resolution
No verified alias in ArrHub’s table; the name stands as the register spells it.
Each device the register lists under licence 111495, 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 |
|---|---|---|---|
| 1062676JSON | VARIPULSE BI-DIRECTIONAL ABLATION CATHETER | 2024-07-11 | null |
Source: Health Canada MDALL, device records for licence 111495, retrieved 2026-10-10 22:15 Eastern. Device identifiers link to the agency’s device record.
Regulatory Decision Summaries Health Canada has published for this licence, newest first. Each links to the agency’s record.
Amendment device licence application with conditions, application 406461
Decision date 2026-07-13. Filed 2025-12-16.
Prints 3 terms and conditions:
Amendment device licence application, application 398292
Decision date 2025-08-12. Filed 2025-06-27.
Prints no terms and conditions.
Amendment device licence application, application 395633
Decision date 2025-06-13. Filed 2025-04-24.
Prints no terms and conditions.
New device licence application, application 372566
Decision date 2024-07-11. Filed 2023-12-20.
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.
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
P240006PMA original, product code QZI. FDA decision 6 November 2024. Pair confirmed under the verification protocol by product name, human review, 24 September 2026; reference class pfa_system.
118
Days from the first issued Canadian licence to the FDA decision; the Canadian licence came first. Computed from the two dates.
First seen by ArrHub’s weekly snapshot: 2026-09-20 09:05 Eastern.
The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.
{
"original_licence_no": 111495,
"licence_status": "D",
"licence_status_desc": "Issued/Conditional",
"appl_risk_class": 4,
"licence_name": "VARIPULSE BI-DIRECTIONAL ABLATION CATHETER",
"licence_name_fr": "VARIPULSE BI-DIRECTIONAL ABLATION CATHETER",
"first_licence_status_dt": "2024-07-11",
"end_date": null,
"licence_type_desc": "Single Device",
"company_id": 160433,
"company_name": "BIOSENSE WEBSTER, INC.",
"country_cd": "US",
"city": "Irvine",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=111495&lang=en&type=json",
"verified_at": "2026-09-20T02:17:28.832468+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=111495&type=active&lang=eng",
"company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=160433&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.
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