NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S069 · decided 2011-06-03
Approval details
- PMA number
- P970051
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2011-04-06
- Decision date
- 2011-06-03
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A MODIFIED VERSION OF THE EXTERNAL CP810 SOUND PROCESSOR MAIN BTE MODULE (APPROVED UNDER P970051/S049), CALLED BUILD STANDARD D, WHICH IS PRIMARILY INTENDED TO ALLOW FOR REPAIR OF THE PROCESSOR.
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