NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051 · decided 1998-06-25
Approval details
- PMA number
- P970051
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1997-11-03
- Decision date
- 1998-06-25
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATIONTO ADULTS AND CHILDREN VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
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