FDA.reportPublic FDA data

PMA P000025S102

Device
MED-EL Cochlear Implant System
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S102
Product code
MCM
Decision date
2018-08-10
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Facility change in the manufacturing of cochlear implants SONATA, Mi1000 MED-EL Concert, Mi1200 Synchrony, and of the single use surgical instruments Insertion Test Device (ITD) and Insertion Electrodes (IE).

Current openFDA PMA Record#

Device
MED-EL Cochlear Implant System
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S102
Product code
MCM
Generic name
Implant, cochlear
Decision date
2018-08-10
Decision code
OK30
Date received
2018-07-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Facility change in the manufacturing of cochlear implants SONATA, Mi1000 MED-EL Concert, Mi1200 Synchrony, and of the single use surgical instruments Insertion Test Device (ITD) and Insertion Electrodes (IE).