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 | COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S019 |
Date Received | 07/05/2005 |
Decision Date | 07/25/2005 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS TO UPDATE NON-ESSENTIAL LABELING AND A MANUAL FOR TROUBLESHOOTING FM SYSTEMS WHICH MAY BE USED ITH THE TEMPO+. |
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