PMA P000015S011
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S011
- Product code
- MCM
- Decision date
- 2009-11-12
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S011
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2009-11-12
- Decision code
- APPR
- Date received
- 2009-10-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS.