PMA P000025S082

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S082
Product code: MCM
Decision date: 2015-12-03
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A CHANGE TO THE MAGNET MATERIAL USED TO MANUFACTURETHE MI1200 SYNCHRONY MAGNET ASSEMBLIES AND THE MI1200 REPLACEMENT MAGNETS. THE CHANGE IS INTENDED TO REPLACE THE CURRENTLY USED MAGNET MATERIAL WHICH IS DISCONTINUED BY THESUPPLIER.

Current openFDA PMA Record#

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S082
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-12-03
Decision code: APPR
Date received: 2015-09-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE MAGNET MATERIAL USED TO MANUFACTURETHE MI1200 SYNCHRONY MAGNET ASSEMBLIES AND THE MI1200 REPLACEMENT MAGNETS. THE CHANGE IS INTENDED TO REPLACE THE CURRENTLY USED MAGNET MATERIAL WHICH IS DISCONTINUED BY THESUPPLIER.