PMA P130016S006

Device
NUCLEUS 24 HYBRID SYSTEM
Applicant
Cochlear Americas
PMA number
P130016
Supplement
S006
Product code
PGQ
Decision date
2014-06-17
Classification
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Generic name
Cochlear implant with combined electrical stimulation and acoustic amplification
Approval order statement
ACCEPTANCE OF ALTERNATE SOLDER MATERIAL.

Current openFDA PMA Record#

Device
NUCLEUS 24 HYBRID SYSTEM
Applicant
Cochlear Americas
PMA number
P130016
Supplement
S006
Product code
PGQ
Generic name
Cochlear implant with combined electrical stimulation and acoustic amplification
Decision date
2014-06-17
Decision code
OK30
Date received
2014-05-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ACCEPTANCE OF ALTERNATE SOLDER MATERIAL.