NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR ADVANCE
FDA premarket approval P970051/S025 · decided 2003-11-07
Approval details
- PMA number
- P970051
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR ADVANCE
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2003-08-13
- Decision date
- 2003-11-07
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL OF A MARKETING NAME CHANGE FROM NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE TO NUCLEUS 24 CONTOUR ADVANCE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.