Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

FDA Premarket Approval P200039 S002

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

The revised protocol for the post-approval study (pas) referenced above.

• Device: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
• Generic Name: Shockwave Intravascular Lithotripsy System
• Applicant: Shockwave Medical, Inc.
• Date Received: 2021-03-11
• Decision Date: 2021-06-04
• PMA: P200039
• Supplement: S002
• Product Code: QMG
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review: No
• Combination Product: No
• Applicant Address: Shockwave Medical, Inc. 5403 Betsy Ross Drive santa Clara, CA 95054

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