NUCLEUS HYBRID L24 IMPLANT SYSTEM
FDA premarket approval P130016/S019 · decided 2016-10-28
Approval details
- PMA number
- P130016
- Supplement
- S019
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2016-06-15
- Decision date
- 2016-10-28
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.
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