NUCLEUS COCHLEAR IMPLANT SYSTEMS
FDA premarket approval P970051/S094 · decided 2014-01-21
Approval details
- PMA number
- P970051
- Supplement
- S094
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEMS
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2012-08-02
- Decision date
- 2014-01-21
- Days to decision
- 537 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE COCHLEAR INTEGRITY TEST SYSTEM (CITS).
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