|
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 | S060 |
Date Received | 12/16/2011 |
Decision Date | 03/05/2012 |
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 A CHANGE IN THE TOLERANCE LIMITS FOR THE OPUS 1 SPEECH PROCESSOR FREQUENCY MEASUREMENT DURING FINAL INSPECTION OF THE DEVICE. THE REASON FOR THE CHANGE IN THE TOLERANCE LIMITS WAS A CHANGE IN THE OPUS 1 MICROPHONE FROM THE ORIGINAL MICROPHONE KNOWLES EG-3000-CX TO THE KNOWLES EG-23000-CX. |