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. |
|
Device | COMBI 40+ COCHLEAR IMPLANT SYSTEM |
Generic Name | implant, cochlear |
Applicant |
MED-EL CORP. |
furstenweg 77a |
innsbruck 6020 |
|
PMA Number | P000025 |
Supplement Number | S094 |
Date Received | 03/16/2017 |
Decision Date | 03/07/2018 |
Product Code |
MCM
|
Advisory Committee |
Ear Nose & Throat |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval order should be issued for the reinforced electrode variant +FLEXSOFT and the Insertion Electrode (IE) variant FLEXSOFT. |
|
|