MED-EL COCHLEAR IMPLANT SYSTEMS
FDA premarket approval P000025/S039 · decided 2009-04-30
Approval details
- PMA number
- P000025
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL COCHLEAR IMPLANT SYSTEMS
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2009-02-18
- Decision date
- 2009-04-30
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR CHANGES MADE TO THE FOLLOWING USER MANUALS: DIB II (DIAGNOSTIC INTERFACE BOX), OPUS 1, OPUS 2 AND TEMPO+ SPEECH PROCESSORS, RBP (REMOTE BATTERY PACK) AND MICROPHONE TEST DEVICE (MTD).
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