PMA P000025S036

Device
COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S036
Product code
MCM
Decision date
2008-08-27
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED IN INNSBRUCK, AUSTRIA.

Current openFDA PMA Record#

Device
COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S036
Product code
MCM
Generic name
Implant, cochlear
Decision date
2008-08-27
Decision code
APPR
Date received
2008-06-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED IN INNSBRUCK, AUSTRIA.