NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S019 · decided 2002-03-21
Approval details
- PMA number
- P970051
- Supplement
- S019
- 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
- 2001-10-23
- Decision date
- 2002-03-21
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE SP-10 BEHIND-THE-EAR SPEECH PROCESSOR WITH ACE, CIS AND SPEAK SPEECH CODING STRATEGIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ESPRIT3G AND IS INTENDED TO BE USED WITH THE CI24M, CI24R(ST) AND CI24R(CS) COCHLEAR IMPLANTS.
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