Medical device licence · 99810 · Class 4
CARDIOMEMS HF SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 13, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99810
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 13, 2017
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIOMEMS GSM ANTENNA
- CARDIOMEMS HANDHELD
- CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
- CARDIOMEMS HOSPITAL SYSTEM
- CARDIOMEMS HOSPITAL SYSTEM POWER CORD
- CARDIOMEMS PA SENSOR AND DELIVERY SYSTEM
- CARDIOMEMS PATIENT ELECTRONICS SYSTEM
- CARDIOMEMS POWER CORD
- CARDIOMEMS POWER SUPPLY
- CARDIOMEMS PRINTER
- CARDIOMEMS PRINTER POWER CABLES
- CARDIOMEMS PRINTER SERIAL CABLES
- CARDIOMEMS WI-FI ADAPTER
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 “cardiomems”. A notice may cover another product or only some lots: read it to see what it covers.
- CardioMEMS Patient Electronics SystemOctober 18, 2024 · Cardiovascular · Performance · Type II
- CardioMEMS™ Patient Electronics SystemNovember 2, 2023 · Cardiovascular · Performance · Type II
- Cardiomems Patient and Hospital Electronics SystemFebruary 23, 2023 · Cardiovascular · Performance · Type II
- Cardiomems Hospital Electronics SystemFebruary 23, 2023 · Cardiovascular · Performance · Type II
- CardioMEMS Patient and Hospital Electronics System (2018-06-15)June 29, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.