COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S020 · decided 2006-05-31
Approval details
- PMA number
- P000025
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2006-04-17
- Decision date
- 2006-05-31
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- 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.
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