Amendment device licence application, application 356346
Decision date 2023-01-24. Filed 2022-11-30.
Prints no terms and conditions.
Health Canada licence record
Licence 84623
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status I, which the register defines as Issued/Active. First issued 6 December 2010.
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 | 84623 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | FORTIFY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS | licence_name |
| Licence name, French | FORTIFY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS | licence_name_fr |
| Date of the first issued licence | 2010-12-06 | 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 84623, 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.
ABBOTT MEDICAL
15900 Valley View Court
Sylmar CA 91342, US
Company status A
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.
Each device the register lists under licence 84623, 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 |
|---|---|---|---|
| 551428JSON | FORTIFY VR | 2010-12-06 | null |
| 551429JSON | FORTIFY DR | 2010-12-06 | null |
| 573136JSON | FORTIFY ASSURA DR | 2012-04-04 | null |
| 573137JSON | FORTIFY ASSURA VR | 2012-04-04 | null |
Source: Health Canada MDALL, device records for licence 84623, 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 356346
Decision date 2023-01-24. Filed 2022-11-30.
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": 84623,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 4,
"licence_name": "FORTIFY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS",
"licence_name_fr": "FORTIFY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS",
"first_licence_status_dt": "2010-12-06",
"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=84623&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=84623&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.
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