Cochlear Americas400 Inverness Parkway Suite 400englewood Co 80112 Pma Numberp840024 Supplement Numbers094 Date Received04 26 2022 Decision Date10 31 2022 Product Code Mcm Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Cochlear Americas400 Inverness Parkway Suite 400englewood Co 80112 Pma Numberp840024 Supplement Numbers094 Date Received04 26 2022 Decision Date10 31 2022 Product Code Mcm Advisory Committee Ear Nose Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Cochlear Americas400 Inverness Parkway,suite 400englewood, CO 80112 PMA NumberP840024 Supplement NumberS094 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Nucleus Cochlear Implant Systems2022-10-31

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