MED-EL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S084 · decided 2016-09-15
Approval details
- PMA number
- P000025
- Supplement
- S084
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COCHLEAR IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Med-El Corp.
- Date received
- 2015-12-23
- Decision date
- 2016-09-15
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for expanding the indications to include the Electro-acoustic Stimulation (EAS) system that is intended to provide electrical stimulation to the mid- to high-frequency region of the cochlea and acoustic amplification to the low-frequency regions, for candidates with residual low frequency hearing sensitivity. The MED-EL EAS System is indicated for partially deaf individuals aged 18 years and older who have residual hearing sensitivity in the low frequencies sloping to a severe/profound
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