NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN)
FDA premarket approval P890027/S050 · decided 2001-07-24
Approval details
- PMA number
- P890027
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN)
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2001-04-19
- Decision date
- 2001-07-24
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE CRYSTAL INTEGRITY TEST SYSTEM THAT PROVIDES A WAY OF PERFORMING A SERIES OF INTEGRITY CHECKS ON EITHER CURRENT OR PAST GENERATION NUCLEUS COCHLEAR IMPLANTS.
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