PMA P000025S067

Device
MED-EL COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S067
Product code
MCM
Decision date
2013-12-05
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR THE MAESTRO 4.1 SOFTWARE, AN UPDATED VERSION OF THE FITTINGSOFTWARE INTENDED FOR USE WITH THE MED-EL COCHLEAR IMPLANT SYSTEM.

Current openFDA PMA Record#

Device
MED-EL COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S067
Product code
MCM
Generic name
Implant, cochlear
Decision date
2013-12-05
Decision code
APPR
Date received
2012-10-26
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE MAESTRO 4.1 SOFTWARE, AN UPDATED VERSION OF THE FITTINGSOFTWARE INTENDED FOR USE WITH THE MED-EL COCHLEAR IMPLANT SYSTEM.