NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S110 · decided 2014-05-08
Approval details
- PMA number
- P970051
- Supplement
- S110
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2013-06-28
- Decision date
- 2014-05-08
- Days to decision
- 314 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A CHANGE TO THE ASSEMBLY CONSTRUCTION OF EXTERNAL SWITCHES ON THE CP810 SOUND PROCESSOR WITH THE INTENTION OF IMPROVING INGRESS PROTECTION AND THEREFORE CORROSION RESISTANCE.
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