PMA
P940009: PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Scimed Life Systems, Inc.
Key facts
| PMA number | P940009 |
|---|---|
| Trade name | PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Scimed Life Systems, Inc. |
| Product code | LOX |
| Approval date | Sep 29, 1994 |
| Docket number | 94M-0403 |
| Notice date | Dec 15, 1994 |
| FEI number | 1000221040 |
At a glance
- None Supplements
- Sep 29, 1994 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- No Withdrawn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: