COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS
FDA premarket approval P000025/S019 · decided 2005-07-25
Approval details
- PMA number
- P000025
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2005-07-05
- Decision date
- 2005-07-25
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS TO UPDATE NON-ESSENTIAL LABELING AND A MANUAL FOR TROUBLESHOOTING FM SYSTEMS WHICH MAY BE USED ITH THE TEMPO+.
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