NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S114 · decided 2014-04-14
Approval details
- PMA number
- P970051
- Supplement
- S114
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2014-01-15
- Decision date
- 2014-04-14
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR MARKETING AN ACCESSORY, THE AQUA+, FOR USE WITH THE NUCLEUS 5 CP810 AND NUCLEUS 6 CP910/CP920 SOUND PROCESSORS, WHICH ARE CURRENTLY APPROVED FOR USE WITH THE COCHLEAR IMPLANT SYSTEM.
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