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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-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
Classification Namedrug-eluting peripheral transluminal angioplasty catheter
Generic Namedrug-eluting peripheral transluminal angioplasty catheter
Applicant
MEDTRONIC Inc.
3576 unocal pl
santa rosa, CA 95403
PMA NumberP140010
Date Received05/29/2014
Decision Date12/30/2014
Product Code
ONU[ Registered Establishments with ONU ]
Docket Number 15M-0199
Notice Date 01/20/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01566461
Expedited Review Granted? Yes
Combination Product Yes
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S034 S035 S036 
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