PMA P000025S072

Device
COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S072
Product code
MCM
Decision date
2014-01-10
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR AN ALTERNATE WELDING PROCESS.

Current openFDA PMA Record#

Device
COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S072
Product code
MCM
Generic name
Implant, cochlear
Decision date
2014-01-10
Decision code
APPR
Date received
2013-07-10
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR AN ALTERNATE WELDING PROCESS.