PMA P000025S059

Device: MED-EL COCHLEAR IMPLANT SYSTEMS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S059
Product code: MCM
Decision date: 2011-12-16
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE OPUS 2 BATTERY PACK XS WHICH IS AN ADDITIONAL OPTIONAL BATTERY PACK FOR USE WITH THE FOLLOWING APPROVED AUDIO PROCESSORS OF THE MED-EL COCHLEAR IMPLANT (CI) SYSTEM: TEMPO+, OPUS 1 AND OPUS 2.

Current openFDA PMA Record#

Device: MED-EL COCHLEAR IMPLANT SYSTEMS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S059
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2011-12-16
Decision code: APPR
Date received: 2011-10-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE OPUS 2 BATTERY PACK XS WHICH IS AN ADDITIONAL OPTIONAL BATTERY PACK FOR USE WITH THE FOLLOWING APPROVED AUDIO PROCESSORS OF THE MED-EL COCHLEAR IMPLANT (CI) SYSTEM: TEMPO+, OPUS 1 AND OPUS 2.