Necleus Auditory Brainstem Impant System
FDA premarket approval P000015/S025 · decided 2017-09-05
Approval details
- PMA number
- P000015
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Necleus Auditory Brainstem Impant System
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2017-08-07
- Decision date
- 2017-09-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Introduction of an additional quality control step after the coil and hardball welding operation of the CI500 series implants.
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