Therox Inc 17500 Cartwright Rdsuite 100irvine Ca 92614 5846 Pma Numberp170027 Supplement Numbers010 Date Received09 30 2022 Decision Date10 27 2022 Product Code Mwg Advisory Committee Cardiovascular 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 Therox Inc 17500 Cartwright Rdsuite 100irvine Ca 92614 5846 Pma Numberp170027 Supplement Numbers010 Date Received09 30 2022 Decision Date10 27 2022 Product Code Mwg Advisory Committee Cardiovascular 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 P170027S010 TherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS010 Date Received09/30/2022 Decision Date10/27/2022 Product Code MWG  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	TherOx Downstream Console	2022-10-27