Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete
FDA premarket approval P200039/S015 · decided 2025-06-10
Approval details
- PMA number
- P200039
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2025-03-12
- Decision date
- 2025-06-10
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter
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