NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S033 · decided 1996-06-13
Approval details
- PMA number
- P890027
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1996-05-06
- Decision date
- 1996-06-13
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A REDESIGN OF THE MINI COCHLEAR IMPLANT'S INTEGRATED CIRCUIT (IC2401)
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