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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.
 
DeviceRanger™ Paclitaxel-Coated PTA Balloon Catheter
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Three Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP190019
Date Received07/22/2019
Decision Date10/30/2020
Product Code ONU 
Docket Number 20M-2152
Notice Date 11/02/2020
Advisory Committee Cardiovascular
Clinical TrialsNCT03064126
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the Ranger Paclitaxel-Coated PTA Balloon Catheter. This device is indicated for percutaneous transluminal angioplasty (PTA) of de novo or restenotic lesions up to 180 mm in length located in native superficial femoral and proximal popliteal arteries (SFA/PPA) with reference vessel diameters of 4 -7 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S011 S012 S013 S019 S020 S006 S007 S022 S001 S002 S003 S018 
S010 S014 S027 S028 S029 S030 S025 S026 S023 S024  S008 
S009 S015 S016 S017 S004 S005 
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