Therox Inc 17500 Cartwright Rdsuite 100irvine Ca 92614 5846 Pma Numberp170027 Supplement Numbers009 Date Received12 17 2021 Decision Date03 10 2022 Product Code Mwg Advisory Committee Cardiovascular 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 Therox Inc 17500 Cartwright Rdsuite 100irvine Ca 92614 5846 Pma Numberp170027 Supplement Numbers009 Date Received12 17 2021 Decision Date03 10 2022 Product Code Mwg Advisory Committee Cardiovascular 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
TherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS009 Date Received12/17/2021 Decision Date03/10/2022 Product Code MWG  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
 TherOx Downstream System2022-03-10

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