|
Device | COMBI 40+ COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S082 |
Date Received | 09/04/2015 |
Decision Date | 12/03/2015 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |