PMA P970051S132

Device
CP900 SERIES SOUND PROCESSORS
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S132
Product code
MCM
Decision date
2016-02-24
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval for a manufacturing site located at Cochlear Ltd – Macquarie University, 1 University Avenue, Macquarie University, NSW 2066, Australia.

Current openFDA PMA Record#

Device
CP900 SERIES SOUND PROCESSORS
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S132
Product code
MCM
Generic name
Implant, cochlear
Decision date
2016-02-24
Decision code
APPR
Date received
2015-07-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Cochlear Ltd – Macquarie University, 1 University Avenue, Macquarie University, NSW 2066, Australia.