COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S079 · decided 2015-01-20
Approval details
- PMA number
- P000025
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2014-06-09
- Decision date
- 2015-01-20
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MI1200 SYNCHRONY AND MI1200 SYNCHRONY PINCOCHLEAR IMPLANTS, EACH WITH ELECTRODE VARIANTS +STANDARD, +MEDIUM, +COMPRESSED, GB, +FLEX24, +FLEX28, ASSOCIATED SURGICAL TOOLS, REPLACEMENT IMPLANT MAGNET AND NON-MAGNETIC SPACER, AND COMPATIBLE MAGNETS FOR EXTERNAL COMPONENTS.
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