NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S028 · decided 2005-03-01
Approval details
- PMA number
- P970051
- Supplement
- S028
- 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
- 2004-07-01
- Decision date
- 2005-03-01
- Days to decision
- 243 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A NEW RECEIVER/STIMULATOR COMPONENT (CI24RE), A NEW SPEECH PROCESSOR (SP12), THE PIF4 PROGRAMMING INTERFACE, THE CS14 PROGRAMMING SOFTWARE, AND UPGRADED NEURAL RESPONSE TELEMETRY SOFTWARE (EPS5).
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