Shockwave Medical Inc 5403 Betsy Ross Drivesanta Clara Ca 95054 Pma Numberp200039 Supplement Numbers008 Date Received10 11 2022 Decision Date12 13 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 Numbers008 Date Received10 11 2022 Decision Date12 13 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 Registration(s)

FDA Filings

Device
Company
DeviceDate
Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS008 Date Received10/11/2022 Decision Date12/13/2022 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) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter2022-12-13

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