Cardiovascular Systems Inc 651 Campus Drminneapolis Mn 55211 Pma Numberp130005 Supplement Numbers035 Date Received02 18 2022 Decision Date03 11 2022 Product Code Mcx Advisory Committee Cardiovascular 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 Cardiovascular Systems Inc 651 Campus Drminneapolis Mn 55211 Pma Numberp130005 Supplement Numbers035 Date Received02 18 2022 Decision Date03 11 2022 Product Code Mcx Advisory Committee Cardiovascular 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 P130005S035 CARDIOVASCULAR SYSTEMS, INC.651 Campus Drminneapolis, MN 55211 PMA NumberP130005 Supplement NumberS035 Date Received02/18/2022 Decision Date03/11/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Diamondback 360 Coronary Orbital Atherectomy System	2022-03-11