PMA supplement
P140002 S002: MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA PMA supplement · Normal 180 Day Track · Terumo Medical Corporation
Key facts
| Original PMA | P140002 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Terumo Medical Corporation |
| Product code | NIP |
| Received date | May 6, 2016 |
| Decision date | Mar 8, 2017 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: