NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S096 · decided 2013-08-02
Approval details
- PMA number
- P970051
- Supplement
- S096
- 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
- 2012-08-27
- Decision date
- 2013-08-02
- Days to decision
- 340 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE NUCLEUS 6 COCHLEAR IMPLANT SYSTEM, A NEW SUITE OF EXTERNAL ACCESSORIES AND PROGRAMMING SOFTWARE TO BE USED WITH THE NUCLEUS 24 COCHLEAR IMPLANT, INCLUDING EXTERNAL SOUND PROCESSORS (CP910 AND CP920), USER REMOTE ASSISTANTS (CR210 AND CR230), INTRAOPERATIVE REMOTE ASSISTANT (CR220), AND PROGRAMMING SOFTWARE (CUSTOM SOUND SUITE 4 COMPRISED OF CUSTOM SOUND 4 AND CUSTOM SOUND EP 4).
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