PMA
P790017: USCI DILATATION CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Medtronic, Ireland
Key facts
| PMA number | P790017 |
|---|---|
| Trade name | USCI DILATATION CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Medtronic, Ireland |
| Owner/operator | Medtronic, Inc. |
| Product code | LOX |
| Approval date | Mar 24, 1980 |
| Docket number | 80M-0246 |
| Notice date | Jul 18, 1980 |
| Establishment registration | 9612164 |
| FEI number | 3002806434 |
At a glance
- 10–99 Supplements
- Oct 27, 2010 Latest supplement decision
- No Withdrawn
- No 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: