MED-EL Cochlear Implant System
FDA premarket approval P000025/S104 · decided 2019-07-19
Approval details
- PMA number
- P000025
- Supplement
- S104
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2018-07-30
- Decision date
- 2019-07-19
- Days to decision
- 354 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for expanding the cochlear implantation indications to include patients 5 years and above with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear.
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