PMA supplement
P200039 S010: Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters
FDA PMA supplement · Real-Time Process · Shockwave Medical, Inc.
Key facts
| Original PMA | P200039 |
|---|---|
| Supplement number | S010 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters |
| Generic name | Shockwave intravascular lithotripsy system |
| Applicant | Shockwave Medical, Inc. |
| Product code | QMG |
| Received date | Dec 27, 2022 |
| Decision date | Mar 22, 2023 |
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: