Nucleus Hybrid Cochlear Implant System
FDA premarket approval P130016/S034 · decided 2018-03-16
Approval details
- PMA number
- P130016
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus Hybrid Cochlear Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2018-02-15
- Decision date
- 2018-03-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Addition of a supplier for the CP900 Series Standard Tamper Resistant Battery Cover.
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