NUCLEUS CI532 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S133 · decided 2016-03-16
Approval details
- PMA number
- P970051
- Supplement
- S133
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS CI532 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2015-07-31
- Decision date
- 2016-03-16
- Days to decision
- 229 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a new member of the CI500 series implant family in the Nucleus® Cochlear Implant System, the CI532 cochlear implant.
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