PMA P000025S080

Device
MAESTRO COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S080
Product code
MCM
Decision date
2014-09-12
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
ALTERNATE ELECTRODE SUPPLIER.

Current openFDA PMA Record#

Device
MAESTRO COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S080
Product code
MCM
Generic name
Implant, cochlear
Decision date
2014-09-12
Decision code
OK30
Date received
2014-08-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE ELECTRODE SUPPLIER.