NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S011 · decided 2000-11-01
Approval details
- PMA number
- P970051
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2000-07-21
- Decision date
- 2000-11-01
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- MODIFICATION OF THE ELECTRODE FOR THE NUCLEUS CI24 COCHLEAR IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM WITH THE FOLLOWING CHANGES TO THE INDICATIONS FOR USE: 1) APPROVAL TO IMPLANT INDIVIDUALS, AGE 18 YEARS AND OLDER, WHO OBTAIN LIMITED BENEFIT FROM AMPLIFICATION AS DEFINED BY TEST SCORES OF <=50% CORRECT IN THE EAR TO BE IMPLANTED, (<=60% IN THE BEST AIDED LISTENING CONDITION) ON TAPE RECORDED TESTS OF OPEN SET SENTENCE REC
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