|
Device | MED EL C40+ COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S031 |
Date Received | 01/23/2008 |
Decision Date | 04/18/2008 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATIONS AS FOLLOWS: 1) ADAPTION OF ENCLOSED TESTS AT HEADER INCOMING INSPECTION; 2) CHANGE IN INCOMING INSPECTION PROCEDURE FOR CABLES OF REMOTE BATTERY PACK; 3) INTRODUCTION OF SILICONE MIXING MACHINE; 4)CHANGE IN MANUFACTURING PROCEDURE FOR WELDING OF COIL; 5) ALTERNATIVE EQUIPMENT TO MEASURE STRENGTH OF MAGNETS; 6) CHANGES TO ELECTRODE MOULDS; 7) CHANGE IN SPRINT; AND 8) NEW MOULD SHAPE. |