Innova Vascular Self-Expanding Stent with Delivery System

FDA premarket approval P140028 · Stent, Superficial Femoral Artery

PMA numberP140028

Approval

Applicant
Boston Scientific Corporation
Received
December 10, 2014
Decision date
July 21, 2015 (APPR)
Supplements
86, latest August 21, 2026
Product code
NIP – Stent, Superficial Femoral Artery

Official FDA PMA record

Approval order statement

APPROVAL FOR THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR: THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE VESSEL DIAMETERS FROM 4.0 MM TO 7.0 MM AND LESION LENGTHS UP TO 190 MM.