NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S012 · decided 2001-01-16
Approval details
- PMA number
- P970051
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2000-11-29
- Decision date
- 2001-01-16
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR MODIFICATION TO THE FIRMWARE, COMPONENTS AND LABELING OF THE PORTABLE PROGRAMMING SYSTEM (PPS) WITH NO CHANGE TO THE CURRENTY APPROVED INDICATIONS FOR USE.
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