Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2

FDA Premarket Approval P200039 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2
• Generic Name: Shockwave Intravascular Lithotripsy System
• Applicant: 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
• Date Received: 2022-06-03
• Decision Date: 2022-09-01
• PMA: P200039
• Supplement: S007
• Product Code: QMG
• Advisory Committee: Cardiovascular
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Shockwave Medical, Inc.; 5403 Betsy Ross Drive; santa 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 Combination ProductNo Approval Order Statement ; approval For A Modification To Your Generator Enclosure

Supplemental Filings

Supplement Number	Date	Supplement Type
P200039		Original Filing
S009	2022-12-08	Normal 180 Day Track No User Fee
S008	2022-10-11	Real-time Process
S007	2022-06-03	Real-time Process
S006	2021-12-22	Real-time Process
S005
S004	2021-10-22	Real-time Process
S003	2021-07-01	30-day Notice
S002	2021-03-11	Normal 180 Day Track No User Fee
S001	2021-03-10	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
00195451000119	P200039	000
00195451000102	P200039	000
00195451000096	P200039	000
00195451000089	P200039	000
00195451000034	P200039	008
00195451000027	P200039	008
00195451000010	P200039	008
00195451000003	P200039	008