Shockwave Medical Inc 5403 Betsy Ross Drivesanta Clara Ca 95054 Pma Numberp200039 Supplement Numbers009 Date Received12 08 2022 Decision Date02 02 2023 Product Code Qmg Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 Numbers009 Date Received12 08 2022 Decision Date02 02 2023 Product Code Qmg Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 P200039S009 Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS009 Date Received12/08/2022 Decision Date02/02/2023 Product Code QMG  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No	Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac	2023-02-02