NUCLEUS HYBRID L24 IMPLANT SYSTEM
FDA premarket approval P130016/S009 · decided 2015-04-08
Approval details
- PMA number
- P130016
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2014-09-24
- Decision date
- 2015-04-08
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: 1) ADDITION OF THE IMPLANT EAR, ELECTRIC ONLY TEST CONDITION, AND 2) MODIFICATION OF THE TESTING SCHEDULE TO INCLUDE A TIERED APPROACH.
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