FDA.reportPublic FDA data

PMA P000015S019

Device
Nucleus ABI541 Auditory Brainstem Implant
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S019
Product code
MHE
Decision date
2017-04-21
Classification
Implant, Auditory Brainstem
Generic name
Implant, auditory brainstem
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 ABI541 Auditory Brainstem Implant
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S019
Product code
MHE
Generic name
Implant, auditory brainstem
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.