Saluda Medical Pty Ltdlevel 1 407 Pacific Highwayartarmon Nsw 2 Pma Numberp190002 Supplement Numbers006 Date Received04 12 2022 Decision Date05 12 2022 Product Code Lgw Advisory Committee Neurology 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 Saluda Medical Pty Ltdlevel 1 407 Pacific Highwayartarmon Nsw 2 Pma Numberp190002 Supplement Numbers006 Date Received04 12 2022 Decision Date05 12 2022 Product Code Lgw Advisory Committee Neurology 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 P190002S006 SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS006 Date Received04/12/2022 Decision Date05/12/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Saluda Medical Evoke SCS System	2022-05-12