PMA P130016S029
- Device
- Nucleus 24 Hybrid System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S029
- Product code
- PGQ
- Decision date
- 2017-07-06
- Classification
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- External supplier, Jabil Circuit in China, to be added as an alternate supplier of the CP800 Series Tamper resistant Battery Cover, CP800 Series Battery Holder and Nucleus Battery Holder components. A change was also requested to the solder material used in the battery holder printed circuit board assembly (PCBA).
Current openFDA PMA Record#
- Device
- Nucleus 24 Hybrid System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S029
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2017-07-06
- Decision code
- OK30
- Date received
- 2017-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- External supplier, Jabil Circuit in China, to be added as an alternate supplier of the CP800 Series Tamper resistant Battery Cover, CP800 Series Battery Holder and Nucleus Battery Holder components. A change was also requested to the solder material used in the battery holder printed circuit board assembly (PCBA).