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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 Coronary Intravascular Lithotripsy (IVL) Cathete
Generic NameShockwave intravascular lithotripsy system
ApplicantShockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara, CA 95054
PMA NumberP200039
Supplement NumberS015
Date Received03/12/2025
Decision Date06/10/2025
Product Code QMG 
Advisory Committee Cardiovascular
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  
the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter
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