NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT
FDA premarket approval P970051/S015 · decided 2002-06-06
Approval details
- PMA number
- P970051
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2001-03-19
- Decision date
- 2002-06-06
- Days to decision
- 444 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11+11+2M DOUBLE ARRAY COCHLEAR IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH 11+11+2M DOUBLE ARRAY AND IS INDICATED FOR PATIENTS WHO HAVE COCHLEAR OSSIFICATION PREVENTING FULL INSERTION OF A STANDARD NUCLEUS 24 COCHLEAR IMPLANT ELECTRODE ARRAY.
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