NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S155 · decided 2017-01-19
Approval details
- PMA number
- P970051
- Supplement
- S155
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2016-12-21
- Decision date
- 2017-01-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Addition of an alternative PCB supplier for the CP900 Sound Processor. This update will add AT&S, an already approved Cochlear vendor, as an addition to the existing CP900 Sound Processor PCB supplier, GS Swiss
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