Medical device licence · 12803 · Class 2
AMPLATZER SIZING BALLOON
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed October 8, 1999; ended November 4, 2009. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 12803
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- October 8, 1999
- Ended
- November 4, 2009
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMPLATZER SIZING BALLOON
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 “amplatzer”. 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
- Amplatzer Torqvue Delivery SystemMarch 26, 2025 · Cardiovascular · Performance · Type II
- AMPLATZER STEERABLE DELIVERY SHEATHNovember 19, 2021 · Cardiovascular · Labelling and packaging · Type II
- Amplatzer TorqVue Low Profile Delivery System (2021-03-08)March 25, 2021 · Medical devices · Medical devices · Type II
- Amplatzer Septal Occluder - Risk of Erosion - For the PublicApril 14, 2014 · Medical devices · Product safety
- Amplatzer Septal Occluder - Risk of Erosion - For Health ProfessionalsApril 14, 2014 · Medical devices · Product safety
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.