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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.
 
Trade NameNIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980001
Date Received01/28/1998
Decision Date08/11/1998
Withdrawal Date 08/13/2007
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 99M-1696
Notice Date 06/09/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the nir on(tm) ranger(tm) and nir on(tm) ranger(tm) w/sox(tm) premounted stent systems. The device is indicated for improving coronary luminal diamter in the following patient subsets: a)patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length <25 mm) with a reference vessel diameter of 3. 0 to 4. 0 mm; b) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2. 5 to 4. 0 mm; c) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesion length < 30 mm and reference vessel diamter in the range of 3. 0 to 4. 0mm.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S006 S008 S009 S010 S011 
S012 S013 S014 S016 S017 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S035 S036 S037 S038 S039 S040 
S041 S043 
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