PMA
P070014: LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Bard Peripheral Vascular, Inc.
Key facts
| PMA number | P070014 |
|---|---|
| Trade name | LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Bard Peripheral Vascular, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | NIP |
| Approval date | Feb 13, 2009 |
| Docket number | 09M-0127 |
| Notice date | Mar 10, 2009 |
| Establishment registration | 2020394 |
| FEI number | 1220748 |
At a glance
- 10–99 Supplements
- Jun 10, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: