MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
FDA premarket approval P000025/S063 · decided 2013-06-06
Approval details
- PMA number
- P000025
- Supplement
- S063
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2012-08-10
- Decision date
- 2013-06-06
- Days to decision
- 300 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR NEW LABELING THAT DESCRIBES CONDITIONS FOR SAFE MAGNETIC RESONANCE (MR) IMAGING AT 0.2 AND 1.5 TESLA FIELD STRENGTHS AND RADIATION THERAPY OF PATIENTS IMPLANTED WITH THE MED-EL COCHLEAR IMPLANT SYSTEMS WHICH INCLUDE THE PULSARCI100, SONATATI100, MED-EL CONCERT, MED-EL CONCERT PIN IMPLANTS.
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