Amendment device licence application, application 399714
Decision date 2025-12-22. Filed 2025-07-29.
Prints no terms and conditions.
ABBOTT MEDICAL
15900 Valley View Court
Sylmar CA 91342, US
Company status A
Health Canada licence record
Licence 107649
AVEIR LEADLESS PACEMAKER
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status D, which the register defines as Issued/Conditional. First issued 22 April 2022.
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 | 107649 | original_licence_no |
| Licence status | D (Issued/Conditional) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | AVEIR LEADLESS PACEMAKER | licence_name |
| Licence name, French | AVEIR LEADLESS PACEMAKER | licence_name_fr |
| Date of the first issued licence | 2022-04-22 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | Single Device | licence_type_desc |
| Company identification number | 168438 | company_id |
Source: Health Canada MDALL, licence 107649, 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.
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 107649, with the date it was added. Later additions do not change the date of the first issued licence.
Decision summaries
Regulatory Decision Summaries Health Canada has published for this licence, newest first. Each links to the agency’s record.
Amendment device licence application, application 397243
Decision date 2025-08-11. Filed 2025-06-03.
Prints no terms and conditions.
Amendment device licence application, application 385791
Decision date 2025-03-25. Filed 2024-11-27.
Prints no terms and conditions.
Amendment device licence application, application 361247
Decision date 2023-08-14. Filed 2023-03-30.
Prints no terms and conditions.
New device licence application, application 337105
Decision date 2022-04-22. Filed 2021-10-12.
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.
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.
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=107649&lang=en&type=json
{
"original_licence_no": 107649,
"licence_status": "D",
"licence_status_desc": "Issued/Conditional",
"appl_risk_class": 4,
"licence_name": "AVEIR LEADLESS PACEMAKER",
"licence_name_fr": "AVEIR LEADLESS PACEMAKER",
"first_licence_status_dt": "2022-04-22",
"end_date": null,
"licence_type_desc": "Single Device",
"company_id": 168438,
"company_name": "ABBOTT MEDICAL",
"country_cd": "US",
"city": "Sylmar",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=107649&lang=en&type=json",
"verified_at": "2026-09-20T02:17:29.236013+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=107649&type=active&lang=eng",
"company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=168438&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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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.
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