PMA P000025S009

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S009
Product code: MCM
Decision date: 2003-08-27
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE COMBI 40+ SYSTEM MEDIUM ACTIVE ELECTRODE ARRAY (C40+M) TO BE PART OF THE C40+ COCHLEAR IMPLANT SYSTEM (IMPLANT C40+ WITH STANDARD C40+, SPLIT C40+ GB, AND COMPRESSED C40+ S ELECTRODE ARRAYS).

Current openFDA PMA Record#

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S009
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-08-27
Decision code: APPR
Date received: 2003-03-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE COMBI 40+ SYSTEM MEDIUM ACTIVE ELECTRODE ARRAY (C40+M) TO BE PART OF THE C40+ COCHLEAR IMPLANT SYSTEM (IMPLANT C40+ WITH STANDARD C40+, SPLIT C40+ GB, AND COMPRESSED C40+ S ELECTRODE ARRAYS).