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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, coronary
Generic Namestent, coronary
one scimed place
maple grove, MN 55311-1566
PMA NumberP980033
Date Received08/03/1998
Decision Date11/16/2001
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 02M-0203
Notice Date 05/09/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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