Nucleus 24 Hybrid System
FDA premarket approval P130016/S029 · decided 2017-07-06
Approval details
- PMA number
- P130016
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus 24 Hybrid System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2017-06-07
- Decision date
- 2017-07-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- External supplier, Jabil Circuit in China, to be added as an alternate supplier of the CP800 Series Tamper resistant Battery Cover, CP800 Series Battery Holder and Nucleus Battery Holder components. A change was also requested to the solder material used in the battery holder printed circuit board assembly (PCBA).
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