Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant
FDA premarket approval P000025/S114 · decided 2020-09-25
Approval details
- PMA number
- P000025
- Supplement
- S114
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2020-03-30
- Decision date
- 2020-09-25
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the 1) Mi1260 SONATA 2 (with S-Vector Magnet); 2) optional tool S-Vector Magnet Replacement Kit; and 3) new S-Vector Magnet for use with the approved Mi1250 SYNCHRONY 2 (PIN).
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