NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S093 · decided 2013-01-03
Approval details
- PMA number
- P970051
- Supplement
- S093
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2012-07-31
- Decision date
- 2013-01-03
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A NEW VERSION OF THE CUSTOM SOUND SOFTWARE FOR PROGRAMMING OF THE NUCLEUS COCHLEAR IMPLANTS, TO BE KNOWN AS CUSTOM SOUND 3.3.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.