PMA
P880065: MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Boston Scientific Corp
Key facts
| PMA number | P880065 |
|---|---|
| Trade name | MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LOX |
| Approval date | Sep 19, 1990 |
| Docket number | 90M-0319 |
| Notice date | Oct 23, 1990 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 1–9 Supplements
- Jan 7, 2004 Latest supplement decision
- Yes Withdrawn
- No 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: