PMA P000025S006

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S006
Product code: MCM
Decision date: 2003-03-18
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR BROADENING THE INDICATION OF THE C40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE CHILDREN AGED TWELVE MONTHS OR OLDER.

Current openFDA PMA Record#

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S006
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-03-18
Decision code: APPR
Date received: 2002-11-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR BROADENING THE INDICATION OF THE C40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE CHILDREN AGED TWELVE MONTHS OR OLDER.