NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA premarket approval P000015/S017 · decided 2016-12-21
Approval details
- PMA number
- P000015
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2016-11-23
- Decision date
- 2016-12-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Manufacturing change to increase the inspection tolerance for the thickness of the silicone over the implant coil.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.