Amendment device licence application, application 399552
Decision date 2025-12-01. Filed 2025-07-23.
Prints no terms and conditions.
BOSTON SCIENTIFIC CORPORATION
4100 Hamline Avenue North
St. Paul MN 55112-5798, US
Company status A
Health Canada licence record
Licence 92976
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status I, which the register defines as Issued/Active. First issued 14 March 2014.
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 | 92976 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) | licence_name |
| Licence name, French | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) | licence_name_fr |
| Date of the first issued licence | 2014-03-14 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | Device Family | licence_type_desc |
| Company identification number | 102065 | company_id |
Source: Health Canada MDALL, licence 92976, 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.
Resolution
No verified alias in ArrHub’s table; the name stands as the register spells it.
Devices on this licence
Each device the register lists under licence 92976, 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 |
|---|---|---|---|
| 595802JSON | AUTOGEN ICD | 2014-03-14 | null |
| 595803JSON | DYNAGEN ICD | 2014-03-14 | null |
| 595804JSON | INOGEN ICD | 2014-03-14 | null |
| 595805JSON | ORIGEN ICD | 2014-03-14 | null |
| 828880JSON | RESONATE HF ICD | 2018-02-15 | null |
| 828881JSON | RESONATE HF ICD-MRI | 2018-02-15 | null |
| 828882JSON | RESONATE EL ICD | 2018-02-15 | null |
| 828883JSON | RESONATE EL ICD-MRI | 2018-02-15 | null |
| 828884JSON | MOMENTUM EL ICD | 2018-02-15 | null |
| 828885JSON | CHARISMA EL ICD | 2018-02-15 | null |
| 828886JSON | CHARISMA EL ICD-MRI | 2018-02-15 | null |
| 828887JSON | VIGILIANT EL ICD | 2018-02-15 | null |
| 828888JSON | VIGILIANT EL ICD-MRI | 2018-02-15 | null |
| 828889JSON | PERCIVA HF ICD | 2018-02-15 | null |
| 828890JSON | PERCIVA HF ICD-MRI | 2018-02-15 | null |
| 828891JSON | PERCIVA ICD | 2018-02-15 | null |
| 828892JSON | PERCIVA ICD-MRI | 2018-02-15 | null |
| 828893JSON | AUTOGEN ICD-MRI | 2018-02-15 | null |
Source: Health Canada MDALL, device records for licence 92976, 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.
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=92976&lang=en&type=json
{
"original_licence_no": 92976,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 4,
"licence_name": "IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)",
"licence_name_fr": "IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)",
"first_licence_status_dt": "2014-03-14",
"end_date": null,
"licence_type_desc": "Device Family",
"company_id": 102065,
"company_name": "BOSTON SCIENTIFIC CORPORATION",
"country_cd": "US",
"city": "St. Paul",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=92976&lang=en&type=json",
"verified_at": "2026-09-20T02:17:27.608944+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=92976&type=active&lang=eng",
"company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=102065&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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