NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S121 · decided 2014-09-09
Approval details
- PMA number
- P970051
- Supplement
- S121
- 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
- 2014-06-09
- Decision date
- 2014-09-09
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR CHANGES TO THE FIRMWARE OF THE CP900 SERIES (NUCLEUS 6) SOUND PROCESSOR AND CR200 SERIES REMOTE ASSISTANTS WHICH WILL ALLOW THE USE OF WIRELESS ACCESSORIES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.