COMBI 40+COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S017 · decided 2008-07-10
Approval details
- PMA number
- P000025
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Trade name
- COMBI 40+COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2004-12-17
- Decision date
- 2008-07-10
- Days to decision
- 1301 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH PULSARCI100 IMPLANTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH PULSARCI100 IMPLANTS AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: 1) ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE A SEVERE TO PROFOUND, BILATERAL SENSONNEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FORM APPROPRIATELY FITTED BINAURAL HEARING AIDS [NOTE: THIS HEARING LOSS MAY BE EVIDENCED BY
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