PMA P000025S048

Device
COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S048
Product code
MCM
Decision date
2010-10-01
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
ADDITION OF ANOTHER SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY COMPONENT.

Current openFDA PMA Record#

Device
COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S048
Product code
MCM
Generic name
Implant, cochlear
Decision date
2010-10-01
Decision code
OK30
Date received
2010-05-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF ANOTHER SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY COMPONENT.