PMA P970051S181

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S181
Product code
MCM
Decision date
2018-09-10
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
New internal electrode supplier for the rechargeable battery assemblies.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S181
Product code
MCM
Generic name
Implant, cochlear
Decision date
2018-09-10
Decision code
OK30
Date received
2018-08-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New internal electrode supplier for the rechargeable battery assemblies.