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 WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S007 |
Date Received | 12/10/2002 |
Decision Date | 06/05/2003 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF AN INDICATION FOR USE ALLOWING THE USE OF MAGNETIC RESONANCE IMAGING (MRI) AT 0.2 TESLA FOR PATIENTS IMPLANTED WITH COMBI 40+ COCHLEAR IMPLANTS (C40+, C40+S AND C40+GB ELECTRODE ARRAYS). |
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