NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S054 · decided 2010-02-17
Approval details
- PMA number
- P970051
- Supplement
- S054
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2009-10-05
- Decision date
- 2010-02-17
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A CHANGE IN THE ALLOWABLE TOLERANCES OF THE SILICONE OVERMOLD IN THE DISTAL PORTION OF THE RECEIVING COIL FOR THE CI500 SERIES COCHLEAR IMPLANTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.