Medical device licence · 107723 · Class 3
AXONICS SNM SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 4, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107723
- Licence holder
- Axonics, Inc.Irvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 4, 2022
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXONICS SNM SYSTEM - REMOTE CONTROL
- AXONICS SNM SYSTEM NEUROSTIMULATOR RECHARGE-FREE
- CLINICIAN PROGRAMMER
- DILATOR AND SHEATH
- DIRECTIONAL GUIDE
- FORAMEN NEEDLE - LONG
- FORAMEN NEEDLE - SHORT
- LEAD IMPLANT KIT
- NEEDLE TEST STIM.CABLE
- STIMULATION GROUND CABLE
- TINED LEAD
- TINED LEAD TEST STIM.CABLE
- TORQUE WRENCH
- TUNNELING TOOL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.