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. |
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Device | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD) |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S005 |
Date Received | 10/15/2002 |
Decision Date | 10/29/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AS A MODIFICATION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AND IS INDICATED FOR USE WHERE THERE IS PLANNED ACCESS TO THE INNER EAR DURING SURGERY. |
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