Shockwave Medical Inc 5403 Betsy Ross Drivesanta Clara Ca 95054 Pma Numberp200039 Supplement Numbers007 Date Received06 03 2022 Decision Date09 01 2022 Product Code Qmg Advisory Committee Cardiovascular 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 Shockwave Medical Inc 5403 Betsy Ross Drivesanta Clara Ca 95054 Pma Numberp200039 Supplement Numbers007 Date Received06 03 2022 Decision Date09 01 2022 Product Code Qmg Advisory Committee Cardiovascular 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 P200039S007 Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS007 Date Received06/03/2022 Decision Date09/01/2022 Product Code QMG  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2	2022-09-01