- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S019
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2026-02-20
- Decision code
- APPR
- Date received
- 2025-11-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter with higher pulse rate and shorter pause time than the C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter approved under P200039/S015