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Health Canada licence record

Licence 84623

FORTIFY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

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.

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.

FieldValueField name
Licence number84623original_licence_no
Licence statusI (Issued/Active)licence_status
Application risk class4appl_risk_class
Licence nameFORTIFY IMPLANTABLE CARDIOVERTER DEFIBRILLATORSlicence_name
Licence name, FrenchFORTIFY IMPLANTABLE CARDIOVERTER DEFIBRILLATORSlicence_name_fr
Date of the first issued licence2010-12-06first_licence_status_dt
Date of cancellationnullend_date
Licence typeDevice Familylicence_type_desc
Company identification number168438company_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.

Company

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.

Devices on this licence

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 IDTrade nameAdded to licenceRemoved
551428JSONFORTIFY VR2010-12-06null
551429JSONFORTIFY DR2010-12-06null
573136JSONFORTIFY ASSURA DR2012-04-04null
573137JSONFORTIFY ASSURA VR2012-04-04null

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.

Decision summaries

Regulatory Decision Summaries Health Canada has published for this licence, newest first. Each links to the agency’s record.

RDS12830JSON

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.

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=84623&lang=en&type=json
{
  "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.

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.

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