NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA premarket approval P000015/S002 · decided 2002-01-07
Approval details
- PMA number
- P000015
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2001-07-23
- Decision date
- 2002-01-07
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE MOST RECENT SOFTWARE VERSION FOR THE NEURAL RESPONSE TELEMETRY (NRTV3) TO BE USED WITH THIS DEVICE.
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