Amendment device licence application, application 380507
Decision date 2024-08-20. Filed 2024-07-02.
Prints no terms and conditions.
BOSTON SCIENTIFIC CORPORATION
300 Boston Scientific Way
Marlborough MA 01752, US
Company status A
Health Canada licence record
Licence 99352
RHYTHMIA HDX 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 27 June 2017.
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 | 99352 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 3 | appl_risk_class |
| Licence name | RHYTHMIA HDX MAPPING SYSTEM | licence_name |
| Licence name, French | RHYTHMIA HDX MAPPING SYSTEM | licence_name_fr |
| Date of the first issued licence | 2017-06-27 | first_licence_status_dt |
| Date of cancellation | null | end_date |
| Licence type | System | licence_type_desc |
| Company identification number | 139858 | company_id |
Source: Health Canada MDALL, licence 99352, 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 99352, 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 |
|---|---|---|---|
| 826170JSON | RHYTHMIA HDX INSTALL BUNDLE ROW MAPPING SYSTEM | 2017-06-27 | null |
| 826171JSON | RHYTHMIA HDX SIGNAL STATION | 2017-06-27 | null |
| 826172JSON | RHYTHMIA HDX WORKSTATION PC | 2017-06-27 | null |
| 826173JSON | RHYTHMIA HDX LOCALIZATION GENERATOR | 2017-06-27 | null |
| 826174JSON | RHYTHMIA HDX LOCALIZATION GENERATOR CABLE | 2017-06-27 | null |
| 826175JSON | RHYTHMIA HDX BREAKOUT BOX | 2017-06-27 | null |
| 826176JSON | RHYTHMIA HDX ABLATION CONNECTION BOX | 2017-06-27 | null |
| 826177JSON | RHYTHMIA HDX IEC ECG OUT BOX | 2017-06-27 | null |
| 826178JSON | RHYTHMIA HDX AAMI ECG OUT BOX | 2017-06-27 | null |
| 826179JSON | RHYTHMIA HDX FOOT SWITCH | 2017-06-27 | null |
| 826180JSON | RHYTHMIA HDX BREAKOUT BOX CABLE | 2017-06-27 | null |
| 826181JSON | RHYTHMIA HDX 72 INTRACARDIAC OUT CABLE | 2017-06-27 | null |
| 826182JSON | RHYTHMIA HDX PATCH CABLE | 2017-06-27 | null |
| 826184JSON | RHYTHMIA HDX IEC ECG IN CABLE | 2017-06-27 | null |
| 826185JSON | RHYTHMIA HDX AAMI ECG IN CABLE | 2017-06-27 | null |
| 826186JSON | RHYTHMIA HDX CARDIOLAB DIRECT CONNECT ECG | 2017-06-27 | null |
| 826187JSON | RHYTHMIA HDX CARDIOLAB DIRECT CONNECT IC | 2017-06-27 | null |
| 826189JSON | RHYTHMIA HDX CLEARSIGN DIRECT CONNECT ECG | 2017-06-27 | null |
| 826190JSON | RHYTHMIA HDX CLEARSIGN DIRECT CONNECT ORION | 2017-06-27 | null |
| 826191JSON | RHYTHMIA HDX CLEARSIGN DIRECT CONNECT IC A/B | 2017-06-27 | null |
| 826192JSON | RHYTHMIA HDX STIMULATOR JUMPER CABLE | 2017-06-27 | null |
| 833099JSON | EGM OUT TO SIGNAL STATION CABLE - STOCKERT | 2018-01-25 | null |
| 833103JSON | EGM OUT TO SIGNAL STATION CABLE - IBI | 2018-01-25 | null |
| 1026943JSON | RYTHMIA HDX MAPPING SYSTEM SOFTWARE | 2020-12-04 | null |
| 1044462JSON | RHYTHMIA HDX MAPPING SYSTEM - LOCATION REFERENCE PATCH KIT | 2022-08-05 | null |
| 1068080JSON | RHYTHMIA HDX V6.0 INSTALL | 2024-08-20 | null |
| 1068081JSON | FORCE COMPUTATION SW MODULE V2.1 | 2024-08-20 | null |
| 1075603JSON | OPAL HDX MAPPING SYSTEM EVALUATION ROW | 2025-02-17 | null |
| 1075604JSON | OPAL HDX MAPPING SYSTEM INSTALL BUNDLE ROW | 2025-02-17 | null |
| 1075605JSON | OPAL HDX MAPPING SYSTEM SIGNAL STATION | 2025-02-17 | null |
| 1075606JSON | OPAL HDX MAPPING SYSTEM WORKSTATION PC | 2025-02-17 | null |
| 1075607JSON | RHYTHMIA HDX V6.0.1 INSTALL | 2025-02-17 | null |
| 1077483JSON | BSC 6.1 INSTALLATION USB | 2025-04-04 | null |
| 1077484JSON | FORCE COMPUTATION MODULE 3.0 USB | 2025-04-04 | null |
| 1086124JSON | OPAL HDX 6.5 INSTALLATION USB | 2025-11-28 | null |
| 1087653JSON | OPAL HDX MAPPING SYSTEM - LOCATION REFERENCE PATCH KIT | 2026-01-14 | null |
| 1092179JSON | OPAL HDX 7.0 SOFTWARE INSTALLATION USB | 2026-05-15 | null |
| 1096953JSON | OPAL HDX BREAKOUT BOX | 2026-08-24 | null |
| 1096954JSON | OPAL HDX ECG OUT BOX (AAMI) | 2026-08-24 | null |
| 1096955JSON | OPAL HDX ECG OUT BOX (IEC) | 2026-08-24 | null |
| 1096956JSON | OPAL HDX 72 INTRACARDIAC OUT CABLE | 2026-08-24 | null |
| 1096957JSON | OPAL HDX ABLATION CONNECTION BOX (IBI/AMPERE) | 2026-08-24 | null |
| 1096958JSON | OPAL HDX BREAKOUT BOX CABLE | 2026-08-24 | null |
| 1096959JSON | OPAL HDX CARDIOLAB DIRECT CONNECT ECG | 2026-08-24 | null |
| 1096960JSON | OPAL HDX CARDIOLAB DIRECT CONNECT IC | 2026-08-24 | null |
| 1096961JSON | OPAL HDX CLEARSIGN DIRECT CONNECT ECG | 2026-08-24 | null |
| 1096962JSON | OPAL HDX CLEARSIGN DIRECT CONNECT IC A/B | 2026-08-24 | null |
| 1096963JSON | OPAL HDX CLEARSIGN DIRECT CONNECT IC ORION | 2026-08-24 | null |
| 1096964JSON | OPAL HDX LOCALIZATION GENERATOR | 2026-08-24 | null |
| 1096965JSON | OPAL HDX LOCALIZATION GENERATOR CABLE | 2026-08-24 | null |
| 1096966JSON | OPAL HDX PATCH CABLE | 2026-08-24 | null |
| 1096967JSON | OPAL HDX STIMULATOR JUMPER CABLE | 2026-08-24 | null |
Source: Health Canada MDALL, device records for licence 99352, 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 318217
Decision date 2020-08-07. Filed 2020-07-03.
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=99352&lang=en&type=json
{
"original_licence_no": 99352,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 3,
"licence_name": "RHYTHMIA HDX MAPPING SYSTEM",
"licence_name_fr": "RHYTHMIA HDX MAPPING SYSTEM",
"first_licence_status_dt": "2017-06-27",
"end_date": null,
"licence_type_desc": "System",
"company_id": 139858,
"company_name": "BOSTON SCIENTIFIC CORPORATION",
"country_cd": "US",
"city": "Marlborough",
"source_url": "https://health-products.canada.ca/api/medical-devices/licence/?id=99352&lang=en&type=json",
"verified_at": "2026-09-20T02:17:27.413259+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=99352&type=active&lang=eng",
"company_record_url": "https://health-products.canada.ca/mdall-limh/information?companyId=139858&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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