FDA.reportPublic FDA data

PMA P000025S091

Device
MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S091
Product code
MCM
Decision date
2016-12-20
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval to allow a maximum of four re-sterilization cycles after initial sterilization for the following products: Mi1200 SYNCHRONY (PIN) Cochlear Implant, Mi1000 MED-EL CONCERT (PIN) Cochlear Implants, SONATATI100 Cochlear Implants, Insertion Electrodes (IE) and Insertion Test Device (ITD).

Current openFDA PMA Record#

Device
MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S091
Product code
MCM
Generic name
Implant, cochlear
Decision date
2016-12-20
Decision code
APPR
Date received
2016-09-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to allow a maximum of four re-sterilization cycles after initial sterilization for the following products: Mi1200 SYNCHRONY (PIN) Cochlear Implant, Mi1000 MED-EL CONCERT (PIN) Cochlear Implants, SONATATI100 Cochlear Implants, Insertion Electrodes (IE) and Insertion Test Device (ITD).