NUCLEUS HYBRID L24 IMPLANT SYSTEM
FDA premarket approval P130016/S002 · decided 2014-07-01
Approval details
- PMA number
- P130016
- Supplement
- S002
- Supplement type
- Real-Time Process
- 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
- 2014-04-02
- Decision date
- 2014-07-01
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR AN MR INDICATION AT 1.5 TESLA UNDER SPECIFIC SCANNING CONDITIONS WITH THE MAGNET SURGICALLY REMOVED PRIOR TO THE MR SCAN, FOR THE HYBRID L24 IMPLANT SYSTEM.
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