NUCLEUS AUDITORY BRAINSTEM IMPLANT
FDA premarket approval P000015/S014 · decided 2016-07-21
Approval details
- PMA number
- P000015
- Supplement
- S014
- 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
- 2016-06-23
- Decision date
- 2016-07-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Addition of automated slot cutting of the sorting ring for implant production.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.