MED-EL CONCERT IMPLANT
FDA premarket approval P000025/S064 · decided 2012-11-01
Approval details
- PMA number
- P000025
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL CONCERT IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2012-09-04
- Decision date
- 2012-11-01
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO THE STIMULATOR HOUSING COMPONENT OF THE MI1000 MED-EL CONCERT IMPLANT THAT IS INTENDED TO CORRECT AN ERROR OF DIMENSIONAL TOLERANCE OF THE HOUSING COMPONENTS USED IN THE MANUFACTURING OF THE DEVICES.
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