PMA P000025S050

Device: MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S050
Product code: MCM
Decision date: 2011-07-22
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR AN UPDATED VERSION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANTSYSTEM REFERRED TO AS MAESTRO 2010 CONSISTING OF THE FOLLOWING FEATURES: 1) A THINNER VERSION OF THE SONATATI- 100 COCHLEAR IMPLANT, THE MI1000 MED-EL CONCERT;2) SEVERAL DESIGN AND MANUFACTURING UPDATES RELATED TO THE INTRODUCTION OF THE MI1000 MEDEL CONCERT; 3) NEW TASKS AND FUNCTIONALITIES ADDED TO THE MAESTRO FITTING SOFTWARE IN MAESTRO 4.0; 4) A SELECTION OF NEW COLORS AVAILABLE FOR THE OPUS 2 AUDIO PROCESSOR AND; 5) A NEW, MORE ENERGY-EFFICIENT, AUDIO PROCESSOR COIL CALLED D-COIL.

Current openFDA PMA Record#

Device: MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S050
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2011-07-22
Decision code: APPR
Date received: 2010-12-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN UPDATED VERSION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANTSYSTEM REFERRED TO AS MAESTRO 2010 CONSISTING OF THE FOLLOWING FEATURES: 1) A THINNER VERSION OF THE SONATATI- 100 COCHLEAR IMPLANT, THE MI1000 MED-EL CONCERT;2) SEVERAL DESIGN AND MANUFACTURING UPDATES RELATED TO THE INTRODUCTION OF THE MI1000 MEDEL CONCERT; 3) NEW TASKS AND FUNCTIONALITIES ADDED TO THE MAESTRO FITTING SOFTWARE IN MAESTRO 4.0; 4) A SELECTION OF NEW COLORS AVAILABLE FOR THE OPUS 2 AUDIO PROCESSOR AND; 5) A NEW, MORE ENERGY-EFFICIENT, AUDIO PROCESSOR COIL CALLED D-COIL.