New device licence application, application 345625
Decision date 2023-03-01. Filed 2022-03-31.
Prints no terms and conditions.
BOSTON SCIENTIFIC CORPORATION
300 Boston Scientific Way
Marlborough MA 01752, US
Company status A
Health Canada licence record
Licence 108971
POLARX CARDIAC CRYOABLATION SYSTEM
Medical device licence on Health Canada’s active licence listing (MDALL). Class IV. Status I, which the register defines as Issued/Active. First issued 1 March 2023.
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 | 108971 | original_licence_no |
| Licence status | I (Issued/Active) | licence_status |
| Application risk class | 4 | appl_risk_class |
| Licence name | POLARX CARDIAC CRYOABLATION SYSTEM | licence_name |
| Licence name, French | POLARX CARDIAC CRYOABLATION SYSTEM | licence_name_fr |
| Date of the first issued licence | 2023-03-01 | 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 108971, 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 108971, 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 |
|---|---|---|---|
| 1016740JSON | POLARX SHORT TIP CRYO-BALLOON CATHETER | 2023-03-01 | null |
| 1016741JSON | POLARX LONG TIP CRYO-BALLOON CATHETER | 2023-03-01 | null |
| 1016742JSON | POLARMAP CIRCULAR MAPPING CATHETER | 2023-03-01 | null |
| 1016743JSON | POLARSHEATH STEERABLE SHEATH 12F | 2023-03-01 | null |
| 1016744JSON | SMARTFREEZE CRYOABLATION SYSTEM CONSOLE | 2023-03-01 | null |
| 1016745JSON | SMARTFREEZE INTER-CONNECTION BOX | 2023-03-01 | null |
| 1016746JSON | SMARTFREEZE CRYO-CABLE | 2023-03-01 | null |
| 1016747JSON | SMARTFREEZE CATHETER EXTENSION CABLE | 2023-03-01 | null |
| 1016748JSON | SMARTFREEZE EP ELECTRICAL CABLE | 2023-03-01 | null |
| 1016749JSON | SMARTFREEZE DIAPHRAGM MOVEMENT SENSOR | 2023-03-01 | null |
| 1016750JSON | SMARTFREEZE ESOPHAGEAL TEMPERATURE SENSOR CABLE | 2023-03-01 | null |
| 1041698JSON | POLARX FIT SHORT TIP CRYOABLATION BALLOON CATHETER | 2023-03-01 | null |
| 1041699JSON | POLARX FIT LONG TIP CRYOABLATION BALLOON CATHETER | 2023-03-01 | null |
| 1041700JSON | SMARTFREEZE REMOTE CONTROL | 2023-03-01 | null |
| 1041701JSON | SMARTFREEZE CRYO-CONSOLE FOOT SWITCH | 2023-03-01 | null |
| 1041702JSON | SMARTFREEZE PRESSURE SENSOR CABLE | 2023-03-01 | null |
Source: Health Canada MDALL, device records for licence 108971, 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.
New device licence application, application 345625
Decision date 2023-03-01. Filed 2022-03-31.
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=108971&lang=en&type=json
{
"original_licence_no": 108971,
"licence_status": "I",
"licence_status_desc": "Issued/Active",
"appl_risk_class": 4,
"licence_name": "POLARX CARDIAC CRYOABLATION SYSTEM",
"licence_name_fr": "POLARX CARDIAC CRYOABLATION SYSTEM",
"first_licence_status_dt": "2023-03-01",
"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=108971&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=108971&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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