Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp000015 Supplement Numbers048 Date Received09 07 2022 Decision Date12 06 2022 Product Code Mhe Advisory Committee Ear Nose Throat Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp000015 Supplement Numbers048 Date Received09 07 2022 Decision Date12 06 2022 Product Code Mhe Advisory Committee Ear Nose Throat Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P000015S048 Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS048 Date Received09/07/2022 Decision Date12/06/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Nucleus 24 Auditory Brainstem Implant System	2022-12-06