Cochlear Nucleus® System
FDA premarket approval P970051/S237 · decided 2025-09-02
Approval details
- PMA number
- P970051
- Supplement
- S237
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Cochlear Nucleus® System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2025-08-01
- Decision date
- 2025-09-02
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- This revision includes data from an IDE study (G190269) to complete the pediatric recruitment arm of this PAS. These additional data are from 23 subjects whose audiometric inclusion criteria overlap with the inclusion criteria for this PAS.
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