Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)

FDA Premarket Approval P200039 S004

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.

Pre-market Approval Supplement Details

Approval for use of the 1-wire printed circuit board in the catheter connector

DeviceShockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
Generic NameShockwave Intravascular Lithotripsy System
ApplicantShockwave Medical, Inc.
Date Received2021-10-22
Decision Date2022-01-04
PMAP200039
SupplementS004
Product CodeQMG 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
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

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