Shockwave Intravascular Litbotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

FDA Premarket Approval P200039

Pre-market Approval Supplement Details

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.

DeviceShockwave Intravascular Litbotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Generic NameShockwave Intravascular Lithotripsy System
ApplicantShockwave Medical, Inc.
Date Received2020-08-25
Decision Date2021-02-12
PMAP200039
SupplementS
Product CodeQMG 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Shockwave Medical, Inc. 5403 Betsy Ross Drive santa Clara, CA 95054

Supplemental Filings

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Supplement NumberDateSupplement Type
P200039Original Filing

NIH GUDID Devices

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