Hybrid Implant System
FDA premarket approval P130016/S044 · decided 2020-12-30
Approval details
- PMA number
- P130016
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Hybrid Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2020-10-02
- Decision date
- 2020-12-30
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a new in-house terminal sterilization process to be used with a new sterilizer.
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