PMA P000025S020

Device: COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S020
Product code: MCM
Decision date: 2006-05-31
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR NEW DIAGNOSTIC INTERFACE BOX II (DIB II). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIB II AND IS INTENDED TO OFFER THE CLINICIAN TOOLS FOR DIFFERENT CLINICAL APPLICATIONS WITH THE MED-EL COCHLEAR IMPLANT SYSTEM.

Current openFDA PMA Record#

Device: COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S020
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2006-05-31
Decision code: APPR
Date received: 2006-04-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR NEW DIAGNOSTIC INTERFACE BOX II (DIB II). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIB II AND IS INTENDED TO OFFER THE CLINICIAN TOOLS FOR DIFFERENT CLINICAL APPLICATIONS WITH THE MED-EL COCHLEAR IMPLANT SYSTEM.