PMA P000025S060

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S060
Product code: MCM
Decision date: 2012-03-05
Classification: Implant, Cochlear
Generic name: Implant, cochlear
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.

Current openFDA PMA Record#

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S060
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2012-03-05
Decision code: APPR
Date received: 2011-12-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.