Nucleus® Auditory Brainstem Implant
FDA premarket approval P000015/S052 · decided 2023-12-13
Approval details
- PMA number
- P000015
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus® Auditory Brainstem Implant
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2023-11-13
- Decision date
- 2023-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- introduction of new manufacturing processes for making battery subcomponents of the CP1000 and CP1100 sound processors
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.