Device Dossier

Catheter, angioplasty, balloon dilatation

Device Dossier for Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class IIa, sponsor Compliance Management…

Intended purpose

The Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulate.

TGA Public Summary