# P150023: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System

- Pathway: PMA
- Applicant: Abbott Vascular, Inc.
- Decided: Jul 5, 2016 after 370 days
- Product code: PNY (Absorbable Coronary Drug-Eluting Stent)
- Device class: 3
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 26, 2017 · Class I · Z-2151-2017: Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and

Source page: https://510kreport.com/device/P150023
Methodology: https://510kreport.com/methodology