PMA
P970052: FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Endologix, Inc.
Key facts
| PMA number | P970052 |
|---|---|
| Trade name | FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Endologix, Inc. |
| Owner/operator | Endologix LLC |
| Product code | LOX |
| Approval date | Feb 20, 1998 |
| Docket number | 98M-0162 |
| Notice date | Mar 20, 1998 |
| Establishment registration | 3011063223 |
| FEI number | 3011063223 |
At a glance
- 1–9 Supplements
- May 19, 1998 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- Yes Withdrawn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: