Mi1200 Magnet Assembly
FDA premarket approval P000025/S090 · decided 2016-11-22
Approval details
- PMA number
- P000025
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mi1200 Magnet Assembly
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2016-08-29
- Decision date
- 2016-11-22
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the addition of a spring ring inside the magnet housing of the implanted Mi1200 Magnet Assembly.
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