NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)
FDA premarket approval P840024/S086 · decided 2002-12-27
Approval details
- PMA number
- P840024
- Supplement
- S086
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2002-12-16
- Decision date
- 2002-12-27
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR MODIFICATION OF THE COIL/CABLE OF THE ESPRIT 3G SPEECH PROCESSOR TO ENABLE NUCLEUS 22 USERS TO ACCESS THE TECHNOLOGICAL BENEFITS OF THE ESPRIT 3G.
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