PMA supplement
P140028 S001: INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corporation
Key facts
| Original PMA | P140028 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Boston Scientific Corporation |
| Product code | NIP |
| Received date | Aug 19, 2015 |
| Decision date | Sep 21, 2015 |
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: