Nucleus Hybrid Cochlear Implant System
FDA premarket approval P130016/S027 · decided 2017-06-13
Approval details
- PMA number
- P130016
- Supplement
- S027
- 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
- 2017-05-16
- Decision date
- 2017-06-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Introduction of the new CBO Sprint Cleanroom at the Cochlear Brisbane Operations (CBO) manufacturing site.
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