PMA
P230026: Lacrosse NSE ALPHA Coronary Dilatation Catheter
FDA PMA · Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring · NIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.)
Key facts
| PMA number | P230026 |
|---|---|
| Trade name | Lacrosse NSE ALPHA Coronary Dilatation Catheter |
| Generic name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Applicant | NIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.) |
| Product code | NWX |
| Approval date | Jun 6, 2024 |
| FEI number | 3007835716 |
At a glance
- 1–9 Supplements
- Jul 22, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: