PMA P000015S010
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S010
- Product code
- MCM
- Decision date
- 2007-12-31
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR USE OF CUSTOM SOUND 2.0 AND THE FREEDOM SOUND PROCESSOR IN RECIPIENTS OF THE NUCLEUS AUDITORY BRAINSTEM IMPLANT.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S010
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2007-12-31
- Decision code
- APPR
- Date received
- 2007-12-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USE OF CUSTOM SOUND 2.0 AND THE FREEDOM SOUND PROCESSOR IN RECIPIENTS OF THE NUCLEUS AUDITORY BRAINSTEM IMPLANT.