PMA
P140028: INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Boston Scientific Corporation
Key facts
| PMA number | P140028 |
|---|---|
| Trade name | INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | NIP |
| Approval date | Jul 21, 2015 |
| Docket number | 15M-2618 |
| Notice date | Aug 28, 2015 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Aug 21, 2026 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- No Withdrawn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: