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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.
 
DeviceBOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP060006
Date Received02/21/2006
Decision Date12/11/2008
Product Code NIN 
Docket Number 08M-0646
Notice Date 12/19/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM. THE DEVICE IS INDICATED AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A SINGLE DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESION (<=15 MM IN LENGTH) OF THE RENAL ARTERY, LOCATED WITHIN 5 MM OF THE OPACIFIED AORTIC LUMEN, WITH A REFERENCE VESSEL DIAMETER OF 4.0 ¿ 7.0 MM TO ASSIST IN THE MAINTENANCE OF VESSEL PATENCY.
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 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S043 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S066 S067 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 
S089 S090 S091 S092 S093 S094 S095 S096 S097 S098 S099 S100 
S101 S102 S103 S104 S105 S106 S107 S108 S109 
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