PMA supplement
P040012 S057: ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Abbott Vascular
Key facts
| Original PMA | P040012 |
|---|---|
| Supplement number | S057 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM |
| Generic name | Stent, carotid |
| Applicant | Abbott Vascular |
| Product code | NIM |
| Received date | Sep 26, 2016 |
| Decision date | Jan 5, 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: