NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P840024/S087 · decided 2007-10-16
Approval details
- PMA number
- P840024
- Supplement
- S087
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2007-09-14
- Decision date
- 2007-10-16
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR MODIFICATIONS TO CUSTOM SOUND PROGRAMMING SOFTWARE TO PROVIDE RECEIPTS OF PREVIOUS GENERATION NUCLEUS 22 COCHLEAR IMPLANTS WITH ACCESS TO THE NUCLEUS FREEDOM SPEECH PROCESSOR.
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