NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S146 · decided 2016-06-23
Approval details
- PMA number
- P970051
- Supplement
- S146
- 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
- 2016-05-27
- Decision date
- 2016-06-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Addition of a welding rework process to the existing welding process joining the top shell to the brazed chassis.
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