Medical device licence · 11245 · Class 3
PARTIAL OSSICULAR RECONSTRUCTION IMPLANTS, DENSE HYDROXYLAPATITE
Yes: licensed in Canada
Licence status Issued (active); first licensed September 2, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11245
- Licence holder
- Medtronic Xomed Inc.Jacksonville, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- September 2, 1999
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OFFSET MUSHROOM HEAD PRTL WITH MALLEABLE LINK
- PARTIAL OSSICULAR PROSTHESIS
- PRTL OSSICULAR RECNSTRCN IMPLANTS - NOTCHED HEAD
- PRTL OSSICULAR RECNSTRCTN IMPLANTS - AUST
- PRTL OSSICULAR RECNSTRCTN IMPLANTS - CAUSSE
- PRTL OSSICULAR RECNSTRCTN IMPLANTS - MORETZ OFFSET
- PRTL OSSICULAR RECNSTRCTN IMPLANTS - PRTL OSSICULAR MALLEABLE PROSTHESIS
- PRTL OSSICULAR RECNSTRCTN IMPLANTS - SHEEHY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.