PMA P000015S054
- Device
- Nucleus® 24 Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S054
- Product code
- MHE
- Decision date
- 2024-05-31
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, auditory brainstem
- Approval order statement
- labeling change for the Cochlear Surgical Processor
Current openFDA PMA Record#
- Device
- Nucleus® 24 Auditory Brainstem Implant System
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S054
- Product code
- MHE
- Generic name
- Implant, auditory brainstem
- Decision date
- 2024-05-31
- Decision code
- APPR
- Date received
- 2024-05-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- labeling change for the Cochlear Surgical Processor