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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 5

Device Problems
No Known Device Problem 339
Defective item 39
Material rupture 36
Inflation issue 12
Deflation issue 8
Occlusion within device 6
Burst 4
Retraction problem 3
Difficult to advance 3
Device-device incompatibility 3
Detachment of device or device component 2
No Information 2
Difficult to remove 2
Stretched 1
Material deformation 1
Total Device Problems 461

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