NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S004 · decided 1999-06-09
Approval details
- PMA number
- P970051
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1999-01-08
- Decision date
- 1999-06-09
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for Continuous Interleaved Sampling (CIS) and Advanced Combination Encoders (ACE) speech coding strategies.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.