PMA P000025S054

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S054
Product code: MCM
Decision date: 2012-04-20
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A CHANGE TO THE PACKAGING CONFIGURATION OF YOUR SONATATI100 COCHLEAR IMPLANT AND THE IMPLANT TEMPLATE, SINGLE USE, FOR THE SONATATI100. THIS CHANGE WILL ENABLE THE SONATA SINGLE USE TEMPLATE TO BE SHIPPED TOGETHER WITH THE SONATATI100 COCHLEAR IMPLANT INSIDE THE IMPLANT BOX.

Current openFDA PMA Record#

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S054
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2012-04-20
Decision code: APPR
Date received: 2011-06-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE PACKAGING CONFIGURATION OF YOUR SONATATI100 COCHLEAR IMPLANT AND THE IMPLANT TEMPLATE, SINGLE USE, FOR THE SONATATI100. THIS CHANGE WILL ENABLE THE SONATA SINGLE USE TEMPLATE TO BE SHIPPED TOGETHER WITH THE SONATATI100 COCHLEAR IMPLANT INSIDE THE IMPLANT BOX.