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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) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2
Generic NameShockwave intravascular lithotripsy system
ApplicantShockwave Medical, Inc.
5403 Betsy Ross Dr.
Santa Clara, CA 95054
PMA NumberP200039
Supplement NumberS007
Date Received06/03/2022
Decision Date09/01/2022
Product Code QMG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification to your generator enclosure.
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