Nucleus ABI541 Auditory Brainstem Implant
FDA premarket approval P000015/S019 · decided 2017-04-21
Approval details
- PMA number
- P000015
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus ABI541 Auditory Brainstem Implant
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2017-03-23
- Decision date
- 2017-04-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Addition of an alternate Printed Circuit Board (PCB) supplier for the CP800 and CP900 sound processor coils for the Nucleus 24 Cochlear Implant system, the Nucleus Hybrid L24 implant system and the Nucleus ABI541 Auditory Brainstem Implant system.
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