PMA supplement
P120020 S002: SUPERA PERIPHERAL STENT SYSTEM (SUPERB)
FDA PMA supplement · Normal 180 Day Track No User Fee · Abbott Vascular (Idef Technologies Inc)
Key facts
| Original PMA | P120020 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | SUPERA PERIPHERAL STENT SYSTEM (SUPERB) |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Abbott Vascular (Idef Technologies Inc) |
| Product code | NIP |
| Received date | Apr 8, 2014 |
| Decision date | Oct 20, 2014 |
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: