Medical device licence · 95509 · Class 4
EMBLEM S-ICD SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 5, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95509
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- August 5, 2015
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMBLEM MRI S-ICD PG
- EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM
- EMBLEM S-ICD PROGRAMMER
- EMBLEM S-ICD PULSE GENERATOR
- EMBLEM S-ICD SUBCUTANEOUS ELECTRODE
- EMBLEM S-ICD SUBCUTANEOUS ELECTRODE INSERTION TOOL
- PROGRAMMER SOFTWARE FOR EMBLEM S-ICD
- PROGRAMMER TELEMETRY WAND
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “emblem”. A notice may cover another product or only some lots: read it to see what it covers.
- Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse GeneratorOctober 17, 2023 · Cardiovascular · Performance · Type II
- Emblem MRI S-ICD PGNovember 9, 2022 · Cardiovascular · Performance · Type II
- Emblem S-Icd and Latitude Programming SystemsJuly 25, 2022 · Cardiovascular · Performance · Type II
- EMBLEM S-ICD SUBCUTANEOUS ELECTRODE (2021-09-28)October 15, 2021 · Medical devices · Medical devices · Type II
- EMBLEM S-ICD PULSE GENERATOR & EMBLEM MRI S-ICD PG (2020-12-03)December 18, 2020 · Medical devices · Medical devices · Type II
- EMBLEM S-ICD SUBCUTANEOUS ELECTRODE (2020-12-03)December 18, 2020 · Medical devices · Medical devices · Type II
- EMBLEM S-ICD PULSE GENERATOR & EMBLEM MRI S-ICD PG (2020-12-03)December 18, 2020 · Medical devices · Medical devices · Type II
- Emblem S-ICD ProgrammerJune 21, 2017 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.