Saluda Medical Pty Ltdlevel 1 407 Pacific Highwayartarmon Nsw 2 Pma Numberp190002 Supplement Numbers013 Date Received09 19 2022 Decision Date12 15 2022 Product Code Lgw Advisory Committee Neurology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 Numbers013 Date Received09 19 2022 Decision Date12 15 2022 Product Code Lgw Advisory Committee Neurology Supplement Typereal Time Process 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 Filings

Device Company	Device	Date
PMA P190002S013 SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS013 Date Received09/19/2022 Decision Date12/15/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Saluda Medical Evoke® SCS System	2022-12-15