NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S137 · decided 2016-07-08
Approval details
- PMA number
- P970051
- Supplement
- S137
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2015-11-23
- Decision date
- 2016-07-08
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval requested for 1) a change in indications to allow MRI of implant recipients at 1.5T with the implant magnet in place for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST) provided that a Cochlear-supplied MRI kit is used; 2) a change in indications to allow MRI of implant recipients at 3.0T with the implant magnet removed for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST); and 3) consolidation of MRI-related labeling into a single document that provides ap
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