PMA P970051S087
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S087
- Product code
- MCM
- Decision date
- 2011-11-04
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL TO MODIFY THE LAYOUT OF THE NON-HERMETIC REGION OF THE FEEDTHROUGH ASSEMBLY ON THE CURRENTLY APPROVED CI24RE IMPLANT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S087
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2011-11-04
- Decision code
- APPR
- Date received
- 2011-09-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO MODIFY THE LAYOUT OF THE NON-HERMETIC REGION OF THE FEEDTHROUGH ASSEMBLY ON THE CURRENTLY APPROVED CI24RE IMPLANT OF THE DEVICE.