PMA
P200039: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
FDA PMA · Shockwave intravascular lithotripsy system · Shockwave Medical, Inc.
Key facts
| PMA number | P200039 |
|---|---|
| Trade name | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter |
| Generic name | Shockwave intravascular lithotripsy system |
| Applicant | Shockwave Medical, Inc. |
| Owner/operator | Shockwave Medical, Inc. |
| Product code | QMG |
| Approval date | Feb 12, 2021 |
| Docket number | 21M-0202 |
| Notice date | Feb 18, 2021 |
| Establishment registration | 3015053858 |
| FEI number | 3015053858 |
At a glance
- 10–99 Supplements
- Sep 11, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: