PMA P000025S023

Device: COMBO 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S023
Product code: MCM
Decision date: 2007-09-24
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE OPUS-1 EXTERNAL SPEECH PROCESSOR AND THE MAESTRO 2.0.1, WHICH ARE NEW COMPONENTS OF THE APPROVED COMBI 40+ COCHLEAR IMPLANT SYSTEM AND ARE INDICATED FOR USE ON PATIENTS WHO HAVE BEEN IMPLANTED WITH PULSARCI100 AND/OR SONATATI100 COCHLEAR IMPLANTS. THE SOFTWARE, MAESTRO 2.0.1, IS INTENDED FOR PROGRAMMING THE OPUS-1 SPEECH PROCESSOR, AND IMPLEMENTS TWO NEW SPEECH CODING STRATEGY FEATURES, HIGH DEFINITION CIS (HDCIS) AND FINE STRUCTURE PROCESSING (FSP).

Current openFDA PMA Record#

Device: COMBO 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S023
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2007-09-24
Decision code: APPR
Date received: 2007-03-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE OPUS-1 EXTERNAL SPEECH PROCESSOR AND THE MAESTRO 2.0.1, WHICH ARE NEW COMPONENTS OF THE APPROVED COMBI 40+ COCHLEAR IMPLANT SYSTEM AND ARE INDICATED FOR USE ON PATIENTS WHO HAVE BEEN IMPLANTED WITH PULSARCI100 AND/OR SONATATI100 COCHLEAR IMPLANTS. THE SOFTWARE, MAESTRO 2.0.1, IS INTENDED FOR PROGRAMMING THE OPUS-1 SPEECH PROCESSOR, AND IMPLEMENTS TWO NEW SPEECH CODING STRATEGY FEATURES, HIGH DEFINITION CIS (HDCIS) AND FINE STRUCTURE PROCESSING (FSP).