Armada™ 14 NC PTA Catheter

The Armada™ 14 NC PTA Catheter is a non-compliant, over-the-wire balloon angioplasty catheter designed to dilate stenosis in peripheral blood vessels, including femoral, infrapopliteal, popliteal, and renal arteries, and to treat blockages in dialysis fistulae. It is also indicated for post-dilatation of balloon-expandable stents, resorbable scaffolds, and self-expanding stents in peripheral vasculature.

The subject device features a non-compliant balloon and dual material layer balloon (Pebax/Nylon) for select sizes (3.0–6.0 mm), compared to the predicate device. Both devices have identical intended use, similar functional specifications, materials, and design with an over-the-wire configuration, hydrophobic coating, and balloon sizes ranging from 1.50 to 6.00 mm in diameter.

ISO 10993-1 (2018) for biocompatibility evaluation; FDA Guidance (2023) on ISO 10993-1 application. Bench testing included dimensional inspection, balloon pressure testing, fatigue resistance, coating performance, and simulated use testing per standard evaluation protocols.

The subject device has identical intended use and equivalent technological characteristics to the predicate Armada™ 14 PTA Catheter. Design differences (non-compliant balloon, dual-material layer) and expanded indications (post-dilatation of scaffolds) do not raise new safety or effectiveness concerns. Non-clinical bench and simulated use testing demonstrated all acceptance criteria were met, and biocompatibility assessment showed no new risks, establishing substantial equivalence.