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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:  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 S039 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 S058 S059 S060 S061 S062 S063 
S064 S066 S067 S068 S070 S071 S072 S073 S074 S075 S076 S077 
S078 S080 
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