- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S015
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2025-06-10
- Decision code
- APPR
- Date received
- 2025-03-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter