PMA P000025S064

Device: MED-EL CONCERT IMPLANT
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S064
Product code: MCM
Decision date: 2012-11-01
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A MINOR DESIGN CHANGE TO THE STIMULATOR HOUSING COMPONENT OF THE MI1000 MED-EL CONCERT IMPLANT THAT IS INTENDED TO CORRECT AN ERROR OF DIMENSIONAL TOLERANCE OF THE HOUSING COMPONENTS USED IN THE MANUFACTURING OF THE DEVICES.

Current openFDA PMA Record#

Device: MED-EL CONCERT IMPLANT
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S064
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2012-11-01
Decision code: APPR
Date received: 2012-09-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MINOR DESIGN CHANGE TO THE STIMULATOR HOUSING COMPONENT OF THE MI1000 MED-EL CONCERT IMPLANT THAT IS INTENDED TO CORRECT AN ERROR OF DIMENSIONAL TOLERANCE OF THE HOUSING COMPONENTS USED IN THE MANUFACTURING OF THE DEVICES.