Medical device licence · 14996 · Class 3
TOTAL OSSICULAR RECONSTRUCTION IMPLANTS, FLEX H/A
Yes: licensed in Canada
Licence status Issued (active); first licensed November 30, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 14996
- Licence holder
- Medtronic Xomed Inc.Jacksonville, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- November 30, 1999
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSSICULAR PROSTHESIS - CAUSSE NOTCHED OFFSET MALLEABLE TOTAL
- OSSICULAR PROSTHESIS - CAUSSE-VINCENT NOTCHED TOTAL
- OSSICULAR PROSTHESIS - HABERMAN MALLEABLE OFFSET TOTAL
- PRTL OSSICULAR RECNSTRCTN IMPLANTS - FLEX H/A - PRTL PROTHESIS - MALLEABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.