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

FDA Premarket Approval P200039 S002

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

The revised protocol for the post-approval study (pas) referenced above.

DeviceShockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Generic NameShockwave Intravascular Lithotripsy System
ApplicantShockwave Medical, Inc.
Date Received2021-03-11
Decision Date2021-06-04
PMAP200039
SupplementS002
Product CodeQMG 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
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
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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.