SONATATI100 IMPLANT
FDA premarket approval P000025/S042 · decided 2009-06-12
Approval details
- PMA number
- P000025
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SONATATI100 IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2009-05-04
- Decision date
- 2009-06-12
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE IMPLANT TEMPLATE, SINGLE USE FOR THE SONATATI100 IMPLANT (SONATATI100 TEMPLATE SU).
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