MED-EL CI System
FDA premarket approval P000025/S134 · decided 2025-11-26
Approval details
- PMA number
- P000025
- Supplement
- S134
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL CI System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2025-02-12
- Decision date
- 2025-11-26
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement for the MED-EL CI System for expanding the indication for use. The expanded device indications include children with bilateral hearing loss who meet the following criteria:The MED-EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with de
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