FDA.reportPublic FDA data

PMA P000015S022

Device
Auditory Brainstem Implant
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S022
Product code
MHE
Decision date
2017-07-06
Classification
Implant, Auditory Brainstem
Generic name
Implant, auditory brainstem
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
Auditory Brainstem Implant
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S022
Product code
MHE
Generic name
Implant, auditory brainstem
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).