MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S091 · decided 2016-12-20
Approval details
- PMA number
- P000025
- Supplement
- S091
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2016-09-22
- Decision date
- 2016-12-20
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval to allow a maximum of four re-sterilization cycles after initial sterilization for the following products: Mi1200 SYNCHRONY (PIN) Cochlear Implant, Mi1000 MED-EL CONCERT (PIN) Cochlear Implants, SONATATI100 Cochlear Implants, Insertion Electrodes (IE) and Insertion Test Device (ITD).
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