PMA P130016S024
- Device
- Nucleus Hybrid L24 Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S024
- Product code
- PGQ
- Decision date
- 2017-04-21
- Classification
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Addition of an alternate Printed Circuit Board (PCB) supplier for the CP800 and CP900 sound processor coils for the Nucleus 24 Cochlear Implant system, the Nucleus Hybrid L24 implant system and the Nucleus ABI541 Auditory Brainstem Implant system.
Current openFDA PMA Record#
- Device
- Nucleus Hybrid L24 Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S024
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2017-04-21
- Decision code
- OK30
- Date received
- 2017-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate Printed Circuit Board (PCB) supplier for the CP800 and CP900 sound processor coils for the Nucleus 24 Cochlear Implant system, the Nucleus Hybrid L24 implant system and the Nucleus ABI541 Auditory Brainstem Implant system.