PMA P000025S068
- Device
- MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S068
- Product code
- MCM
- Decision date
- 2013-05-16
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR THE REUSABLE MI1000 PIN DRILL GUIDE WHICH ASSISTS IN THE SURGICAL IMPLANTATION OF THE APPROVED MI1000 CONCERT PIN IMPLANT.
Current openFDA PMA Record#
- Device
- MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S068
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-05-16
- Decision code
- APPR
- Date received
- 2013-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE REUSABLE MI1000 PIN DRILL GUIDE WHICH ASSISTS IN THE SURGICAL IMPLANTATION OF THE APPROVED MI1000 CONCERT PIN IMPLANT.