NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S058 · decided 2009-12-02
Approval details
- PMA number
- P970051
- Supplement
- S058
- Supplement type
- 30-Day Notice
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2009-11-02
- Decision date
- 2009-12-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- CHANGES TO THE MANUFACTURING PROCESS FOR THE WELDING OF THE INTERNAL MAGNET OF THE CI500 SERIES COCHLEAR IMPLANT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.