Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac

FDA Premarket Approval P200039 S009

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 C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac
• Generic Name: Shockwave Intravascular Lithotripsy System
• Applicant: 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
• Date Received: 2022-12-08
• Decision Date: 2023-02-02
• PMA: P200039
• Supplement: S009
• Product Code: QMG
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Pas
• Expedited Review: No
• Combination Product: No
• Applicant Address: Shockwave Medical, Inc.; 5403 Betsy Ross Drive; santa 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 Combination ProductNo Approval Order Statement ; approval For Updated Labeling To Include The Final Results Of Your Continued Follow Up Study

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