NUCLEUS 24 HYBRID SYSTEM
FDA premarket approval P130016/S007 · decided 2014-09-09
Approval details
- PMA number
- P130016
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 HYBRID SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2014-06-09
- Decision date
- 2014-09-09
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR CHANGES TO THE FIRMWARE OF THE CP900 SERIES (NUCLEUS 6) SOUND PROCESSOR AND CR200 SERIES REMOTE ASSISTANTS WHICH WILL ALLOW THE USE OF WIRELESS ACCESSORIES.
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