PMA supplement
P200039 S019: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat
FDA PMA supplement · Normal 180 Day Track · Shockwave Medical, Inc.
Key facts
| Original PMA | P200039 |
|---|---|
| Supplement number | S019 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat |
| Generic name | Shockwave intravascular lithotripsy system |
| Applicant | Shockwave Medical, Inc. |
| Product code | QMG |
| Received date | Nov 19, 2025 |
| Decision date | Feb 20, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: