Nucleus Cochlear Implant System
FDA premarket approval P970051/S197 · decided 2020-08-31
Approval details
- PMA number
- P970051
- Supplement
- S197
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2020-03-04
- Decision date
- 2020-08-31
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a change in electronic assembly design for the Nucleus Cochlear Implant System (CI600 series implants), and for adding Cochlear Brisbane Operations as a supplier of the new electronic assemblies.
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