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

Supplement NumberDateSupplement Type
P200039Original Filing
S009 2022-12-08 Normal 180 Day Track No User Fee
S008 2022-10-11 Real-time Process
S007 2022-06-03 Real-time Process
S006 2021-12-22 Real-time Process
S005
S004 2021-10-22 Real-time Process
S003 2021-07-01 30-day Notice
S002 2021-03-11 Normal 180 Day Track No User Fee
S001 2021-03-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00195451000119 P200039 000
00195451000102 P200039 000
00195451000096 P200039 000
00195451000089 P200039 000
00195451000034 P200039 008
00195451000027 P200039 008
00195451000010 P200039 008
00195451000003 P200039 008

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