PMA P970051S088
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S088
- Product code
- MCM
- Decision date
- 2011-12-20
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A MODIFIED VERSION OF THE APPROVED CP800 SERIES COIL TO ACCOMMODATE THE MAGNET STRENGTH OF 6 THAT IS HIGHER THAN THE STRENGTHS CURRENTLY AVAILABLE.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S088
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2011-12-20
- Decision code
- APPR
- Date received
- 2011-10-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFIED VERSION OF THE APPROVED CP800 SERIES COIL TO ACCOMMODATE THE MAGNET STRENGTH OF 6 THAT IS HIGHER THAN THE STRENGTHS CURRENTLY AVAILABLE.