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PMA P970051S165

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S165
Product code
MCM
Decision date
2017-07-06
Classification
Implant, Cochlear
Generic name
Implant, cochlear
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 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S165
Product code
MCM
Generic name
Implant, cochlear
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).