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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceShockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat
Generic NameShockwave intravascular lithotripsy system
ApplicantShockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara, CA 95054
PMA NumberP200039
Supplement NumberS019
Date Received11/19/2025
Decision Date02/20/2026
Product Code QMG 
Advisory Committee Cardiovascular
Clinical TrialsNCT05966662
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter with higher pulse rate and shorter pause time than the C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter approved under P200039/S015
Post-Approval StudyShow Report Schedule and Study Progress
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