THE MED-EL C40 + COCHLEAR IMPLANT
FDA premarket approval P000025/S085 · decided 2016-04-29
Approval details
- PMA number
- P000025
- Supplement
- S085
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE MED-EL C40 + COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2016-02-01
- Decision date
- 2016-04-29
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for labeling the MED-EL C40+ cochlear implant as conditionally safe for 1.5 Tesla in magnetic resonance (MR) environments, and updating the C40+ labeling with information on radiation therapy and scuba diving for patients and professionals.
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