NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P840024/S055 · decided 1996-02-13
Approval details
- PMA number
- P840024
- Supplement
- S055
- 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
- 1994-10-04
- Decision date
- 1996-02-13
- Days to decision
- 497 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR COMPONENT AND PROCESS CHANGE TO THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE COMPONENT CHANGE CONSISTS OF REPLACING THE LOWER VALUE NPO DIELECTRIC TRIM CAPACITOR WITH THE SAME BX DIELECTRIC MATERIAL AS USED FOR THE HIGHER VALUE TRIM CAPACITOR. THE PROCESS CHANGE CONSISTS OF PREHEATING THE CAPACITORS AND PRINTED CIRCUIT BOARD PRIOR TO SOLDERING THE CAPACITORS TO THE PCB
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