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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 NameBOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Classification Namestent, renal
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP060006
Date Received02/21/2006
Decision Date12/11/2008
Product Code
NIN[ Registered Establishments with NIN ]
Docket Number 08M-0646
Notice Date 12/19/2008
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 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 Order Approval Order
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 
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