PMA P000015S008
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S008
- Product code
- MCM
- Decision date
- 2006-10-05
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- ADDITIONAL ETHYLENE OXIDE (EO) STERILIZER AND CHANGE TO A NEW SIZE OF ETHYLENE OXIDE CANISTER.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S008
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2006-10-05
- Decision code
- OK30
- Date received
- 2006-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL ETHYLENE OXIDE (EO) STERILIZER AND CHANGE TO A NEW SIZE OF ETHYLENE OXIDE CANISTER.