Nucleus® Cochlear Implant System
FDA premarket approval P970051/S164 · decided 2017-11-17
Approval details
- PMA number
- P970051
- Supplement
- S164
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nucleus® Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2017-05-23
- Decision date
- 2017-11-17
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval order for the remote programing of Nucleus Cochlear Implant System using telehealth technology should be issued.
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