Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp130016 Supplement Numbers051 Date Received09 07 2022 Decision Date12 06 2022 Product Code Pgq 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 Numberp130016 Supplement Numbers051 Date Received09 07 2022 Decision Date12 06 2022 Product Code Pgq 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 P130016S051 Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS051 Date Received09/07/2022 Decision Date12/06/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Nucleus Hybrid L24 Cochlear Implant System	2022-12-06