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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 Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantMEDTRONIC Inc.
3576 UNOCAL PL
SANTA ROSA, CA 95403
PMA NumberP140010
Date Received05/29/2014
Decision Date12/30/2014
Product Code ONU 
Docket Number 15M-0199
Notice Date 01/20/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01566461
Expedited Review Granted? Yes
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
FOR THE IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THIS DEVICE IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AFTER PREDILATATION, OF DE NOVO OR RESTENOTIC LESIONS UP TO 180 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S076 S037 S041 S048 S049 S052 S042 S043 S051 S061 S056 S060 
S053 S064 S066 S071 S067 S068 S077 S078 S080 S074 S075  
S018 S019 S011 S012 S001 S002 S003 S021 S022 S023 S024 S028 
S031 S007 S009 S004 S005 S013 S010 S006 S025 S026 S014 S015 
S016 S017 S034 S035 S036 S020 S029 S030 S027 S032 S033 S039 
S046 S047 S050 S044 S045 S058 S059 S073 S062 S072 S070 S063 
S054 S055 
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