PMA
P950020: FLEXATOME CUTTING BALLOON
FDA PMA · Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring · Boston Scientific Corp
Key facts
| PMA number | P950020 |
|---|---|
| Trade name | FLEXATOME CUTTING BALLOON |
| Generic name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | NWX |
| Approval date | Apr 18, 2000 |
| Docket number | 00M-1298 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 100–999 Supplements
- Jan 27, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: