FDA.reportPublic FDA data

PMA P000025S098

Device
MED-EL Cochlear Implants
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S098
Product code
MCM
Decision date
2018-04-20
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval for the following changes to the Medical Procedures Manual (MPM) AW33290 EN US of the labeling: 1) Change to allow diagnostic ultrasound exposure for MED-EL Cochlear Implants;2) Changes related to MRI (MPM section "Magnetic Resonance Imaging (MRI) Safety Information");3) Addition of some introductory text;4) Correction of MRI condition for SONATA and Mi1000 CONCERT (PIN); and5) Editorial changes.

Current openFDA PMA Record#

Device
MED-EL Cochlear Implants
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S098
Product code
MCM
Generic name
Implant, cochlear
Decision date
2018-04-20
Decision code
APPR
Date received
2018-01-22
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the following changes to the Medical Procedures Manual (MPM) AW33290 EN US of the labeling: 1) Change to allow diagnostic ultrasound exposure for MED-EL Cochlear Implants;2) Changes related to MRI (MPM section "Magnetic Resonance Imaging (MRI) Safety Information");3) Addition of some introductory text;4) Correction of MRI condition for SONATA and Mi1000 CONCERT (PIN); and5) Editorial changes.