Medical device licence · 4702 · Class 3
STEALTHSTATION NAVIGATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 7, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 4702
- Licence holder
- Medtronic Navigation, Inc.Lafayette, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 7, 1999
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STEALTHSTATION NAVIGATION SYSTEM - HARDWARE
- STEALTHSTATION NAVIGATION SYSTEM - INSTRUMENT SETS
- TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL
- TRAJECTORY GUIDE KIT, BIOPSY, INTERNAL
- TRAJECTORY GUIDE KIT, CATHETER, ELEVATED
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 “stealthstation”. A notice may cover another product or only some lots: read it to see what it covers.
- StealthStation™ S8 software applicationSeptember 4, 2024 · Neurology · Performance · Type I
- StealthStation S8 ApplicationAugust 14, 2024 · Neurology · Performance · Type II
- Stealthstation S8 ApplicationOctober 17, 2023 · Neurology · Performance · Type II
- Stealthstation S7 – Software, CranialMay 4, 2023 · Neurology · Performance · Type II
- Stealthstation S7 Treatment Guidance SystemDecember 22, 2021 · Neurology · Software defect · Type II
- STEALTHSTATION S7/S8 (2021-03-09)April 8, 2021 · Medical devices · Medical devices · Type II
- StealthStation S7 & Cranial Software system (2019-08-19)September 12, 2019 · Medical devices · Medical devices · Type II
- StealthStation S7 Cranial Software (2018-10-03)November 2, 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.