COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025 · decided 2001-08-20
Approval details
- PMA number
- P000025
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2000-06-29
- Decision date
- 2001-08-20
- Days to decision
- 417 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (COMBI 40+). THE DEVICE IS INTENDED TO PROVIDE THE OPPORTUNITY TO DETECT AND RECOGNIZE AUDITORY INFORMATION THROUGH ELECTRICAL STIMULATION OF THE AUDITORY NERVE FOR SERVER TO PROFOUNDLY HEARING-IMPAIRED INDIVIDUALS WHO OBTAIN LITTLE OR NO BENEFIT FROM CONVENTIONAL ACOUSTIC AMPLIFICATION IN THE BEST-AIDED CONDITION. THE COMBI 40+ IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS OF EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILA
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