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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™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary IVL Catheter
Generic NameShockwave intravascular lithotripsy system
ApplicantShockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara, CA 95054
PMA NumberP200039
Supplement NumberS023
Date Received06/02/2026
Decision Date06/29/2026
Product Code QMG 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of manufacturing and quality control improvements to the catheter lamination process and operating parameters, adhesive tolerances, and related in-process inspections
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