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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBOSTON SCIENTIFIC CORPORATION
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP140028
Date Received12/10/2014
Decision Date07/21/2015
Product Code NIP 
Docket Number 15M-2618
Notice Date 08/28/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01292928
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S075 S076 S077 S078 S079 
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