Amendment device licence application, application 383549
Decision date 2025-01-09. Filed 2024-09-23.
Prints no terms and conditions.
Health Canada licence record
Licence 98243
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status I, which the register defines as Issued/Active. First issued 16 December 2016.
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 | 98243 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | INTELLANAV OPEN-IRRIGATED ABLATION CATHETER | licence_name |
| Licence name, French | INTELLANAV OPEN-IRRIGATED ABLATION CATHETER | licence_name_fr |
| Date of the first issued licence | 2016-12-16 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | Device Family | licence_type_desc |
| Company identification number | 139858 | company_id |
Source: Health Canada MDALL, licence 98243, 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.
BOSTON SCIENTIFIC CORPORATION
300 Boston Scientific Way
Marlborough MA 01752, 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 98243, 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 |
|---|---|---|---|
| 819586JSON | INTELLANAV OPEN-IRRIGATED ABLATION CATHETER - STANDARD CURVE | 2016-12-16 | null |
| 819587JSON | INTELLANAV OPEN-IRRIGATED ABLATION CATHETER - LARGE CURVE | 2016-12-16 | null |
| 819588JSON | INTELLANAV OPEN-IRRIGATED ABLATION CATHETER - ASYMMETRIC CURVE | 2016-12-16 | null |
Source: Health Canada MDALL, device records for licence 98243, 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, application 383549
Decision date 2025-01-09. Filed 2024-09-23.
Prints no terms and conditions.
New device licence application, application 255276
Decision date 2016-12-16. Filed 2016-06-21.
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.
Record pair
No confirmed pair across the two registers for this record.
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": 98243,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 4,
"licence_name": "INTELLANAV OPEN-IRRIGATED ABLATION CATHETER",
"licence_name_fr": "INTELLANAV OPEN-IRRIGATED ABLATION CATHETER",
"first_licence_status_dt": "2016-12-16",
"end_date": null,
"licence_type_desc": "Device Family",
"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=98243&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=98243&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.
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