NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR CHILDREN/ESPRIT 22
FDA premarket approval P890027/S051 · decided 2002-02-19
Approval details
- PMA number
- P890027
- Supplement
- S051
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR CHILDREN/ESPRIT 22
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2001-09-28
- Decision date
- 2002-02-19
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE ADDITION OF A RESISTOR TO THE INTEGRATED CIRCUIT FOR THE ESPRIT 22 SPEECH PROCESSOR.
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