PMA P970051S155

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S155
Product code: MCM
Decision date: 2017-01-19
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Addition of an alternative PCB supplier for the CP900 Sound Processor. This update will add AT&S, an already approved Cochlear vendor, as an addition to the existing CP900 Sound Processor PCB supplier, GS Swiss

Current openFDA PMA Record#

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S155
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2017-01-19
Decision code: OK30
Date received: 2016-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternative PCB supplier for the CP900 Sound Processor. This update will add AT&S, an already approved Cochlear vendor, as an addition to the existing CP900 Sound Processor PCB supplier, GS Swiss