Torax Medical4188 Lexington Avenue Northshoreview Mn 55126 Pma Numberp100049 Supplement Numbers034 Date Received05 10 2022 Decision Date06 09 2022 Product Code Lei Advisory Committee Gastroenterology Urology 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 Torax Medical4188 Lexington Avenue Northshoreview Mn 55126 Pma Numberp100049 Supplement Numbers034 Date Received05 10 2022 Decision Date06 09 2022 Product Code Lei Advisory Committee Gastroenterology Urology 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 P100049S034 TORAX MEDICAL4188 Lexington Avenue Northshoreview, MN 55126 PMA NumberP100049 Supplement NumberS034 Date Received05/10/2022 Decision Date06/09/2022 Product Code LEI  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	LINX Reflux Management System	2022-06-09