PMA P970051S135

Device
COCHLEAR CI500 SERIES IMPLANTS
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S135
Product code
MCM
Decision date
2015-11-12
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
NEW SUPPLIER AND A CHANGE IN THE UPPER TOLERANCE SPECIFICATION OF THE 25 MICRON PLATINUM IRIDIUM WIRE.

Current openFDA PMA Record#

Device
COCHLEAR CI500 SERIES IMPLANTS
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S135
Product code
MCM
Generic name
Implant, cochlear
Decision date
2015-11-12
Decision code
OK30
Date received
2015-10-13
Supplement type
30-Day Notice
Approval order statement
NEW SUPPLIER AND A CHANGE IN THE UPPER TOLERANCE SPECIFICATION OF THE 25 MICRON PLATINUM IRIDIUM WIRE.