PMA P970051S179

Device
Nucleus 24 Cochlear Implant System (Nucleus 7 Sound Processor)
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S179
Product code
MCM
Decision date
2018-05-24
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval for Labeling Enhancements for the Nucleus 7 Sound Processor.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System (Nucleus 7 Sound Processor)
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S179
Product code
MCM
Generic name
Implant, cochlear
Decision date
2018-05-24
Decision code
APPR
Date received
2018-04-27
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for Labeling Enhancements for the Nucleus 7 Sound Processor.