Envoy Medical Corporation4875 White Bear Parkwaywhite Bear Lake Mn 55110 Pma Numberp090018 Supplement Numbers041 Date Received03 23 2022 Decision Date08 24 2022 Product Code Oaf Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Envoy Medical Corporation4875 White Bear Parkwaywhite Bear Lake Mn 55110 Pma Numberp090018 Supplement Numbers041 Date Received03 23 2022 Decision Date08 24 2022 Product Code Oaf Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 P090018S041 ENVOY MEDICAL CORPORATION4875 White Bear Parkwaywhite Bear Lake, MN 55110 PMA NumberP090018 Supplement NumberS041 Date Received03/23/2022 Decision Date08/24/2022 Product Code OAF  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No	Esteem® Totally Implantable Hearing System	2022-08-24