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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drug-eluting peripheral transluminal angioplasty catheter
Definition A Drug-Eluting Peripheral Transluminal Angioplasty Catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide Percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, infrapopliteal, femoral, and iliofemoral, as well as native or synthetic arteriovenous dialysis fistulae.
Product CodeONU
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 0 2 17 20

Device Problems
No Known Device Problem 509
Defective item 58
Material rupture 41
Inflation issue 16
Burst 14
Deflation issue 9
Occlusion within device 6
Difficult to remove 5
Device expiration issue 5
Device-device incompatibility 4
Difficult to advance 3
Retraction problem 3
Material deformation 2
Stretched 2
Detachment of device or device component 2
No Information 2
Torn material 1
Leak 1
Crack 1
Total Device Problems 684

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