PMA
P160024: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
FDA PMA · Iliac covered stent, arterial · Bard Peripheral Vascular, Inc.
Key facts
| PMA number | P160024 |
|---|---|
| Trade name | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT |
| Generic name | Iliac covered stent, arterial |
| Applicant | Bard Peripheral Vascular, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | PRL |
| Approval date | Apr 24, 2017 |
| Docket number | 17M-2594 |
| Notice date | Apr 25, 2017 |
| Establishment registration | 2020394 |
| FEI number | 1220748 |
At a glance
- 10–99 Supplements
- Sep 29, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: