FDA.reportPublic FDA data

PMA P000025S085

Device
THE MED-EL C40 + COCHLEAR IMPLANT
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S085
Product code
MCM
Decision date
2016-04-29
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval for labeling the MED-EL C40+ cochlear implant as conditionally safe for 1.5 Tesla in magnetic resonance (MR) environments, and updating the C40+ labeling with information on radiation therapy and scuba diving for patients and professionals.

Current openFDA PMA Record#

Device
THE MED-EL C40 + COCHLEAR IMPLANT
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S085
Product code
MCM
Generic name
Implant, cochlear
Decision date
2016-04-29
Decision code
APPR
Date received
2016-02-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for labeling the MED-EL C40+ cochlear implant as conditionally safe for 1.5 Tesla in magnetic resonance (MR) environments, and updating the C40+ labeling with information on radiation therapy and scuba diving for patients and professionals.