PMA P000015S001

Device
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S001
Product code
MCM
Decision date
2001-08-01
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR SOFTWARE VERSION R126.

Current openFDA PMA Record#

Device
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S001
Product code
MCM
Generic name
Implant, cochlear
Decision date
2001-08-01
Decision code
APPR
Date received
2001-06-22
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR SOFTWARE VERSION R126.