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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 System with the C2/C2+ Coronary IVL Catheter
Generic NameShockwave intravascular lithotripsy system
ApplicantShockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara, CA 95054
PMA NumberP200039
Supplement NumberS013
Date Received02/07/2024
Decision Date10/24/2024
Product Code QMG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a new Shockwave Medical catheter manufacturing site located at SWAV CR SRL Coyol Free Zone, Building B50.B., El Coyol, Alajuela, Costa Rica and a new Steris AST sterilization facility located at Coyol Free Zone, Building B16, Alajuela, Costa Rica.
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