|Trade Name||INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|
|Classification Name||stent, superficial femoral artery|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the innova vascular self-expanding stent system. This device is indicated for: the innova¿ vascular self-expanding stent system is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (sfa) and/or proximal popliteal artery (ppa) with reference vessel diameters from 4. 0 mm to 7. 0 mm and lesion lengths up to 190 mm.
|Post-Approval Study||Show Report Schedule and Study Progress|