Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System

FDA premarket approval P150023 · Absorbable coronary drug-eluting stent

PMA numberP150023

Approval

Applicant
Abbott Vascular, Inc.
Received
July 1, 2015
Decision date
July 5, 2016 (APWD)
Supplements
9, latest May 30, 2018
Product code
PNY – Absorbable Coronary Drug-Eluting Stent

Official FDA PMA record

Approval order statement

Approval for the ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) System. This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2.5 mm to <=3.75 mm in diameter in lesions <=24 mm in length.