NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P840024/S068 · decided 1997-04-04
Approval details
- PMA number
- P840024
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1996-12-09
- Decision date
- 1997-04-04
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR MARKETING OF THE AUDALLION BEAM FORMING PRE-PROCESSOR AND FOR APPROVAL OF DEVICE EFFECTIVENESS CLAIMS FOR THE AUDALLIN AS USED WIT THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (SPEAK SPEECH PROCESSOR). THE AUDALLION IS INDICATED FOR USE BY ADULTS WHO ARE USING THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM TO AID THEM IN IMPROVING SPEECH UNDERSTADNING IN NOISY ENVIRONMENTS WHEN THE SPEECH AND THE NOISE ARE NOT COMING FROM THE SAME DIRECTION
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