| |
| Trade Name | SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS |
|---|
| Classification Name | stent, superficial femoral artery |
|---|
| Applicant | CORDIS CORP. |
|---|
| PMA Number | P120002 |
|---|
| Date Received | 02/03/2012 |
|---|
| Decision Date | 11/07/2012 |
|---|
| Product Code | |
| Docket Number | 12M-1183 |
|---|
| Notice Date | 12/05/2012 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Clinical Trials |
NCT00739102
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the s. M. A. R. T. Control and s. M. A. R. T. Vascular stent systems. This device is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150 mm and with a reference vessel diameter ranging from 4 mm to 7 mm. |
| Approval Order |
Approval Order
|
| Post-Approval Study | Show Report Schedule and Study Progress |
