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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceShockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Generic Nameshockwave intravascular lithotripsy system
Applicant
Shockwave Medical, Inc.
5403 betsy ross drive
santa clara, CA 95054
PMA NumberP200039
Date Received08/25/2020
Decision Date02/12/2021
Product Code QMG 
Docket Number 21M-0202
Notice Date 02/18/2021
Advisory Committee Cardiovascular
Clinical Trials NCT03595176
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter. The Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Coronary Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
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