NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S037 · decided 2006-05-25
Approval details
- PMA number
- P970051
- Supplement
- S037
- 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
- 2006-04-13
- Decision date
- 2006-05-25
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR 1) SMALLER AND MORE COSMETIC, EAR-LEVEL CONTROLLER (POWERED BY TWO 675 HEARING-AID BATTERIES) AND 2) A RECHARGEABLE LITHIUM-ION BATTERY ? BOTH FOR USE WITH THE MODULAR NUCLEUS FREEDOM SPEECH PROCESSOR.
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