|
Device | SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P120002 |
Date Received | 02/03/2012 |
Decision Date | 11/07/2012 |
Product Code |
NIP |
Docket Number | 12M-1183 |
Notice Date | 12/05/2012 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00739102
|
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 |