PMA P000025S063

Device: MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S063
Product code: MCM
Decision date: 2013-06-06
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order 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.

Current openFDA PMA Record#

Device: MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S063
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2013-06-06
Decision code: APPR
Date received: 2012-08-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.