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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceMED-EL Cochlear Implants
Generic Nameimplant, cochlear
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS098
Date Received01/22/2018
Decision Date04/20/2018
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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.