PMA P970051S092

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S092
Product code
MCM
Decision date
2012-08-24
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
IMPLEMENTATION OF A NEW CLEANING SYSTEM FOR THE IMPLANT ELECTRONIC ASSEMBLIES FOR THE C124RE(CA), C124RE(ST), AND C1422 NUCLEUS COCHLEAR IMPLANTS.

Current openFDA PMA Record#

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S092
Product code
MCM
Generic name
Implant, cochlear
Decision date
2012-08-24
Decision code
OK30
Date received
2012-07-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF A NEW CLEANING SYSTEM FOR THE IMPLANT ELECTRONIC ASSEMBLIES FOR THE C124RE(CA), C124RE(ST), AND C1422 NUCLEUS COCHLEAR IMPLANTS.