Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp130016 Supplement Numbers047 Date Received02 01 2022 Decision Date03 03 2022 Product Code Pgq Advisory Committee Ear Nose Throat Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp130016 Supplement Numbers047 Date Received02 01 2022 Decision Date03 03 2022 Product Code Pgq Advisory Committee Ear Nose Throat Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier 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 P130016S047 Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS047 Date Received02/01/2022 Decision Date03/03/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Nucleus® Hybrid™ L24 Cochlear Implant System	2022-03-03