Medical device licence · 110485 · Class 2
AMULET STEERABLE DELIVERY SHEATH
Yes: licensed in Canada
Licence status Issued (active); first licensed November 28, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110485
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group
- First licensed
- November 28, 2023
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMULET STEERABLE DELIVERY SHEATH
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 “amulet”. A notice may cover another product or only some lots: read it to see what it covers.
- Amplatzer™ Amulet™ Left Atrial Appendage OccluderSeptember 25, 2026 · Cardiovascular · Labelling and packaging · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.