Svelte Medical Systems Inc 675 Central Avenue Suite 2new Providence Nj 07974 Pma Numberp210014 Supplement Numbers001 Date Received01 12 2022 Decision Date04 08 2022 Product Code Niq Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Svelte Medical Systems Inc 675 Central Avenue Suite 2new Providence Nj 07974 Pma Numberp210014 Supplement Numbers001 Date Received01 12 2022 Decision Date04 08 2022 Product Code Niq Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol 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 P210014S001 Svelte Medical Systems, Inc.675 Central Avenue, Suite 2new Providence, NJ 07974 PMA NumberP210014 Supplement NumberS001 Date Received01/12/2022 Decision Date04/08/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No	SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste	2022-04-08