MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S057 · decided 2012-04-30
Approval details
- PMA number
- P000025
- Supplement
- S057
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2011-10-14
- Decision date
- 2012-04-30
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE FOLLOWING: 1) +FLEX28, +FLEX24 AND FLEX24 ELECTRODE VARIANTS FOR THE SONATATI100 AND MIL000 MED-EL CONCERT COCHLEAR IMPLANTS; 2) +STANDARD, +MEDIUM AND +COMPRESSED ELECTRODE VARIANTS FOR THE SONATATI100 COCHLEAR IMPLANT; AND 3) NEW VARIANTS OF THE SINGLE USE SURGICAL INSERTION ELECTRODE TOOL (STANDARD, MEDIUM,COMPRESSED, FLEX24 AND FLEX28).
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