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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.
 
DeviceWALLSTENT ENDOPROSTHESIS
Generic NameStent, central venous
ApplicantBoston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP980033
Date Received08/03/1998
Decision Date11/16/2001
Product Code QKJ 
Docket Number 02M-0203
Notice Date 05/09/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS RP DELIVERY SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (12 MM - 16 MM VENOUS ENDOPROSTHESES). THESE DEVICES ARE INDICATED FOR IMPROVING CENTRAL VENOUS LUMINAL DIAMETER FOLLOWING UNSECCESSFUL ANGIOPLASTY IN PATIENTS ON CHRONIC HEMODIALYSIS WITH STENOSIS OF THE VENOUS OUTFLOW TRACT. UNSUCCESSFUL ANGIOPLASTY IS DEFINED AS RESIDUAL STENOSIS >= 30 PERCENT FOR A VEIN <= 10 MM IN DIAMETER OR >= 50 PERCENT FOR A VEIN > 10 MM IN DIAMETER, A TEAR WHICH INTERRUPTS THE INTEGRITY OF THE INTIMA OR LUMEN, ABRUPT LESION SITE OCCLUSION, OR REFRACTORY SPASM. THE VESSELS THAT CAN BE TREATED WITH THE DEVICE ARE THE INNOMINATE AND SUBCLAVIAN VEINS RANGING FROM 8 MM TO 15 MM IN DIAMETER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S043 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 
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