Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp000015 Supplement Numbers047 Date Received04 26 2022 Decision Date10 31 2022 Product Code Mhe Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp000015 Supplement Numbers047 Date Received04 26 2022 Decision Date10 31 2022 Product Code Mhe Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P000015S047 Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS047 Date Received04/26/2022 Decision Date10/31/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Nucleus Auditory Brainstem Implant	2022-10-31