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,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S001 |
Date Received | 12/18/2001 |
Decision Date | 07/29/2002 |
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 FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, C40+S (COMPRESSED) ELECTRODE ARRAY AND THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, C40+ GB (SPLIT) ELECTRODE ARRAY. |
|
|