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Phosphorylcholine (PC) Coated Biodivysio SV and OC Over-the-Wire (OTW) Stent Delivery Systems

FDA PMA

Class III (US FDA PMA)

PMA P000011

by Abbott Vascular Inc.

Identity

Trade Name
BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM FDA PMA
Generic Name
STENT, CORONARY FDA PMA

Identifiers

PMA Number
P000011 FDA PMA
FDA Product Code
MAF FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The Phosphorylcholine (PC) coated Biodivysio SV and OC over-the-wire (OTW) stent delivery system is a coronary stent system designed for percutaneous transluminal coronary angioplasty. It consists of a phosphorylcholine-coated stent mounted on an over-the-wire delivery catheter, intended to improve coronary luminal diameter in diseased vessels.

This system is supplied sterile for single-use only in the cardiac catheterization laboratory. It is indicated for use in subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions ≤25 mm in length and reference vessel diameter between ≥3.0 mm and ≤4.0 mm. Long-term outcomes beyond six months for this permanent implant are currently unknown.

Frequently asked questions

What is the phosphorylcholine coating on the Biodivysio stent intended to do?

The phosphorylcholine (PC) coating on the Biodivysio stent is designed to improve biocompatibility and reduce thrombogenicity by mimicking the natural phospholipid layer of cell membranes, which may help minimize inflammatory responses and thrombus formation following implantation.

What are the specific lesion and vessel size requirements for using this stent delivery system?

The device is intended for use in de novo native coronary artery lesions with a length of 25 mm or less and a reference vessel diameter ranging from 3.0 mm to 4.0 mm, as specified in the approval documentation for improving coronary luminal diameter in these anatomical constraints.

Is the Biodivysio SV and OC OTW stent delivery system reusable or single-use?

The Phosphorylcholine (PC) coated Biodivysio SV and OC over-the-wire stent delivery system is supplied sterile and is intended for single-use only; reprocessing or reuse is not indicated or supported by the provided device data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Vascular Inc.
FDA Applicant
Abbott Vascular, Inc.

Sources (1)

  • FDA PMA P000011 24 fields · synced Sep 18, 2026