PMA
P050018: ANGIOSCULPT SCORING BALLOON CATHETER
FDA PMA · Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring · Spectranetics Corp.
Key facts
| PMA number | P050018 |
|---|---|
| Trade name | ANGIOSCULPT SCORING BALLOON CATHETER |
| Generic name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Applicant | Spectranetics Corp. |
| Owner/operator | Philips Medical Systems International BV |
| Product code | NWX |
| Approval date | Jan 8, 2007 |
| Docket number | 07M-0032 |
| Notice date | Jan 23, 2007 |
| Establishment registration | 3005462046 |
| FEI number | 3005462046 |
At a glance
- 10–99 Supplements
- Apr 4, 2025 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- No Withdrawn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: