NUCLEUS HYBRID L24 IMPLANT SYSTEM
FDA premarket approval P130016/S016 · decided 2016-09-01
Approval details
- PMA number
- P130016
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2016-02-08
- Decision date
- 2016-09-01
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus HybridL24 Implant System.
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