PMA
P890048: USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Usci, Div. C.R. Bard, Inc.
Key facts
| PMA number | P890048 |
|---|---|
| Trade name | USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Usci, Div. C.R. Bard, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | LOX |
| Approval date | Apr 17, 1991 |
| Docket number | 91M-0157 |
| Notice date | Jun 6, 1991 |
| Establishment registration | 3006082230 |
| FEI number | 3006082230 |
At a glance
- 1–9 Supplements
- Feb 4, 1997 Latest supplement decision
- No Withdrawn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: