Cochlear Nucleus CI600 Series Cochlear Implants
FDA premarket approval P970051/S183 · decided 2019-06-14
Approval details
- PMA number
- P970051
- Supplement
- S183
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cochlear Nucleus CI600 Series Cochlear Implants
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2018-12-17
- Decision date
- 2019-06-14
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a new series of Nucleus Cochlear Implants, the CI600 Series Cochlear Implants, comprising the CI612, CI622 and CI632, and two accessories (Nucleus Non-Magnetic Cassette and Nucleus Replacement Magnet Cassette).
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