PMA
P020037: FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Abbott Vascular, Inc.
Key facts
| PMA number | P020037 |
|---|---|
| Trade name | FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Abbott Vascular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LOX |
| Approval date | Jun 11, 2003 |
| Docket number | 03M-0320 |
| Notice date | Jun 30, 2003 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 1–9 Supplements
- Jan 11, 2008 Latest supplement decision
- No Withdrawn
- Yes 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: