Medical device licence · 97151 · Class 4
PLATINIUM IMPLANTABLE DEFIBRILLATORS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97151
- Licence holder
- Microport Crm S.R.L.Saluggia, VC, Italy
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- June 22, 2016
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PLATINIUM
- PLATINIUM CRT-D
- PLATINIUM DR
- PLATINIUM SONR CRT-D
- PLATINIUM VR
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 “platinium”. A notice may cover another product or only some lots: read it to see what it covers.
- Platinium SonR CRT-D (2018-12-22)January 9, 2019 · Medical devices · Medical devices · Type II
- Platinium SonR CRT-D (2018-07-09)July 19, 2018 · Medical devices · Medical devices · Type II
- Platinium DFR VR ICD, DR ICD, and SonR CRT-D (2018-03-16)March 23, 2018 · 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.