NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S129 · decided 2015-06-23
Approval details
- PMA number
- P970051
- Supplement
- S129
- Supplement type
- Real-Time Process
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2015-03-23
- Decision date
- 2015-06-23
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE CP900 SERIES PROCESSOR COILWHICH MAKES THE CP900 SERIES PROCESSOR COMPATIBLE WITH THE N22 IMPLANT AND ALLOWS RECIPIENTS OF THE N22 IMPLANT ACCESS TO THE NEWEST PROCESSOR TECHNOLOGY.
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