Nucleus ABI541 Auditory Brainstem Implant
FDA premarket approval P000015/S042 · decided 2019-12-13
Approval details
- PMA number
- P000015
- Supplement
- S042
- 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
- 2019-11-13
- Decision date
- 2019-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Manufacturing change of the silicone overmoulding used in the CI500 Series Cochlear Implant and the ABI541 Auditory Brainstem Implant.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.