Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant
FDA premarket approval P000025/S110 · decided 2019-06-04
Approval details
- PMA number
- P000025
- Supplement
- S110
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2019-03-06
- Decision date
- 2019-06-04
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the Mi1200 SYNCHRONY 2 (PIN) implant which incorporates a design change to a central lead exit of the approved Mi1200 SYNCHRONY (PIN) implant.
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