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

FDA premarket approval P200039 · Shockwave intravascular lithotripsy system

PMA numberP200039

Approval

Applicant
Shockwave Medical, Inc.
Received
August 25, 2020
Decision date
February 12, 2021 (APPR)
Supplements
24, latest September 11, 2026
Product code
QMG – Shockwave Intravascular Lithotripsy System

Official FDA PMA record

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.