Amendment device licence application, application 404649
Decision date 2026-03-23. Filed 2025-11-27.
Prints no terms and conditions.
ABBOTT MEDICAL
15900 Valley View Court
Sylmar CA 91342, US
Company status A
Health Canada licence record
Licence 105445
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICDS)
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status I, which the register defines as Issued/Active. First issued 18 November 2020.
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 | 105445 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICDS) | licence_name |
| Licence name, French | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICDS) | licence_name_fr |
| Date of the first issued licence | 2020-11-18 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | Device Family | licence_type_desc |
| Company identification number | 168438 | company_id |
Source: Health Canada MDALL, licence 105445, 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 105445, 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 |
|---|---|---|---|
| 1024054JSON | AVANT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
| 1024055JSON | GALLANT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
| 1024056JSON | ENTRANT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
| 1024057JSON | AVANT DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
| 1024058JSON | GALLANT DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
| 1024059JSON | ENTRANT DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
| 1026366JSON | NEUTRINO NXT DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
| 1026367JSON | NEUTRINO NXT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | 2020-11-18 | null |
Source: Health Canada MDALL, device records for licence 105445, 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.
Amendment device licence application, application 404649
Decision date 2026-03-23. Filed 2025-11-27.
Prints no terms and conditions.
Amendment device licence application, application 376516
Decision date 2024-07-25. Filed 2024-03-27.
Prints no terms and conditions.
Amendment device licence application, application 330396
Decision date 2021-06-10. Filed 2021-04-08.
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=105445&lang=en&type=json
{
"original_licence_no": 105445,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 4,
"licence_name": "IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICDS)",
"licence_name_fr": "IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICDS)",
"first_licence_status_dt": "2020-11-18",
"end_date": null,
"licence_type_desc": "Device Family",
"company_id": 168438,
"company_name": "ABBOTT MEDICAL",
"country_cd": "US",
"city": "Sylmar",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=105445&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=105445&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.
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.
© 2026 ArrHub. Content made available under licence.