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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.
 
DeviceIN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Generic Namedrug-coated peripheral transluminal angioplasty catheter
ApplicantMedtronic Vascular Inc.
3576 unocal place
santa rosa, CA 95403
PMA NumberP190008
Date Received04/03/2019
Decision Date11/21/2019
Product Code PRC 
Docket Number 19M-5534
Notice Date 11/22/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for the IN.PACT AV Paclitaxel-coated PTA Balloon Catheter. The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014 S015 S016 S017 S018 
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