Nucleus Hybrid Implant System
FDA premarket approval P130016/S033 · decided 2018-02-01
Approval details
- PMA number
- P130016
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus Hybrid Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2018-01-02
- Decision date
- 2018-02-01
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Removal of the Laminar Flow Units from cleanrooms.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.