PMA P000025S026

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S026
Product code: MCM
Decision date: 2008-03-14
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE DACAPO SYSTEM WHICH IS AN ALTERNATIVE RECHARGEABLE BATTERY PACK TO POWER THE BEHIND-THE-EAR SPEECH PROCESSOR, AN EXTERNAL COMPONENT OF THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.

Current openFDA PMA Record#

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S026
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2008-03-14
Decision code: APPR
Date received: 2007-07-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE DACAPO SYSTEM WHICH IS AN ALTERNATIVE RECHARGEABLE BATTERY PACK TO POWER THE BEHIND-THE-EAR SPEECH PROCESSOR, AN EXTERNAL COMPONENT OF THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.