|
Device | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S046 |
Date Received | 03/18/2010 |
Decision Date | 09/03/2010 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN MED-EL¿S SUPPLIER OF A CRITICAL COMPONENT WITH DIRECT IMPACT ON THE SAFETY AND EFFICACY OF THE SONATA IMPLANTS. |