Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp130016 Supplement Numbers049 Date Received05 02 2022 Decision Date06 16 2022 Product Code Pgq Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Cochlear Americas13059 East Peakview Avenuecentennial Co 80111 Pma Numberp130016 Supplement Numbers049 Date Received05 02 2022 Decision Date06 16 2022 Product Code Pgq Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol 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 P130016S049 Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No	Nucleus Hybrid L24 Implant System	2022-06-16