Saluda Medical Pty Ltdlevel 1 407 Pacific Highwayartarmon Nsw 2 Pma Numberp190002 Supplement Numbers002 Date Received03 07 2022 Decision Date04 06 2022 Product Code Lgw Advisory Committee Neurology Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 Numbers002 Date Received03 07 2022 Decision Date04 06 2022 Product Code Lgw Advisory Committee Neurology Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P190002S002 SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS002 Date Received03/07/2022 Decision Date04/06/2022 Product Code LGW  Advisory Committee Neurology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Saluda Medical Evoke® SCS System	2022-04-06