PMA supplement
P200039 S021: Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL Catheter
FDA PMA supplement · 135 Review Track For 30-Day Notice · Shockwave Medical, Inc.
Key facts
| Original PMA | P200039 |
|---|---|
| Supplement number | S021 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL Catheter |
| Generic name | Shockwave intravascular lithotripsy system |
| Applicant | Shockwave Medical, Inc. |
| Product code | QMG |
| Received date | Apr 8, 2026 |
| Decision date | Jun 24, 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: