MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S060 · decided 2012-03-05
Approval details
- PMA number
- P000025
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2011-12-16
- Decision date
- 2012-03-05
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- 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.
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