PMA P000025S107

Device
MED-EL Cochlear Implant System
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S107
Product code
MCM
Decision date
2019-02-22
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Addition of a new supplier for a cochlear implant electrode wire.

Current openFDA PMA Record#

Device
MED-EL Cochlear Implant System
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S107
Product code
MCM
Generic name
Implant, cochlear
Decision date
2019-02-22
Decision code
OK30
Date received
2019-01-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new supplier for a cochlear implant electrode wire.