

# PNY · Absorbable Coronary Drug-Eluting Stent

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/PNY

## Overview

- **Product Code:** PNY
- **Device Name:** Absorbable Coronary Drug-Eluting Stent
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150023](/device/P150023.md) | ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM | Abbott Vascular, Inc. | Jul 5, 2016 | APWD |

## Top Applicants

- Abbott Vascular, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/PNY](https://fda.innolitics.com/productcode/PNY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
