NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S034 · decided 2005-10-21
Approval details
- PMA number
- P970051
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2005-09-23
- Decision date
- 2005-10-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR AN ALTERNATIVE CABLE AND CONNECTOR (ALSO KNOWN AS SHOE) TO BE USED WITH THE PREVIOUSLY APPROVED NUCLEUS FREEDOM BODYWORN PROCESSOR. THE ALTERNATIVE CABLE/SHOE HAS BEEN DESIGNED TO BE COMPATIBLE WITH WIRELESS FM COMMUNICATION SYSTEMS MANUFACTURED BY PHONAK HEARING SYSTEMS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.