Amendment device licence application, application 318148
Decision date 2021-01-07. Filed 2020-06-26.
Prints no terms and conditions.
ST. JUDE MEDICAL
One St. Jude Medical Drive
Saint Paul MN 55117, US
Company status A
Health Canada licence record
Licence 97814
ENSITE PRECISION CARDIAC MAPPING SYSTEM
Medical device licence on Health Canada’s active licence listing (MDALL). Class III. Status I, which the register defines as Issued/Active. First issued 13 October 2016.
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 | 97814 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 3 | appl_risk_class |
| Licence name | ENSITE PRECISION CARDIAC MAPPING SYSTEM | licence_name |
| Licence name, French | ENSITE PRECISION CARDIAC MAPPING SYSTEM | licence_name_fr |
| Date of the first issued licence | 2016-10-13 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | System | licence_type_desc |
| Company identification number | 130489 | company_id |
Source: Health Canada MDALL, licence 97814, 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 97814, 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 |
|---|---|---|---|
| 580605JSON | ENSITE VELOCITY - MAIN UNIT | 2016-10-13 | null |
| 817848JSON | ENSITE VELOCITY CARDIAC MAPPING SYSTEM SOFTWARE UPGRADE KIT V5.0 | 2016-10-13 | null |
| 818105JSON | ENSITE PRECISION V.2.0.0 | 2016-10-13 | null |
| 818106JSON | ENSITE PRECISION MODULE, SENSOR ENABLED | 2016-10-13 | null |
| 818107JSON | ENSITE PRECISION FIELD FRAME BRACKET | 2016-10-13 | null |
| 818108JSON | ENSITE PRECISION POWER SUPPLY KIT | 2016-10-13 | null |
| 818110JSON | ENSITE PRECISION PATIENT REFERENCE SENSOR | 2016-10-13 | null |
| 818111JSON | ENSITE PRECISION BEDRAIL MOUNT KIT | 2016-10-13 | null |
| 818112JSON | ENSITE PRECISION FIELD FRAME | 2016-10-13 | null |
| 818113JSON | ENSITE PRECISION LINK, SENSOR ENABLED | 2016-10-13 | null |
| 818120JSON | ENSITE PRECISION FIELD FRAME CABLE | 2016-10-13 | null |
| 821655JSON | ENSITE MEDIGUIDE INTERFACE MODULE | 2016-11-17 | null |
| 1024643JSON | NAVLINK MODULE | 2021-01-07 | null |
| 1024644JSON | ARRAYLINK MODULE | 2021-01-07 | null |
| 1024645JSON | CATHLINK MODULE | 2021-01-07 | null |
| 1024646JSON | RECORDCONNECT | 2021-01-07 | null |
| 1024647JSON | ENSITE VELOCITY SYSTEM DISPLAY WORKSTATION KIT | 2021-01-07 | null |
| 1049240JSON | ENSITE PRECISION SOFTWARE INSTALLATION | 2023-01-30 | null |
| 1049241JSON | ENSITE PRECISION SOFTWARE UPGRADE | 2023-01-30 | null |
Source: Health Canada MDALL, device records for licence 97814, 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=97814&lang=en&type=json
{
"original_licence_no": 97814,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 3,
"licence_name": "ENSITE PRECISION CARDIAC MAPPING SYSTEM",
"licence_name_fr": "ENSITE PRECISION CARDIAC MAPPING SYSTEM",
"first_licence_status_dt": "2016-10-13",
"end_date": null,
"licence_type_desc": "System",
"company_id": 130489,
"company_name": "ST. JUDE MEDICAL",
"country_cd": "US",
"city": "Saint Paul",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=97814&lang=en&type=json",
"verified_at": "2026-09-20T02:17:29.146298+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=97814&type=active&lang=eng",
"company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=130489&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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