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Gianturco-Roubin Coronary Flex-Stent

FDA PMA

Class III (US FDA PMA)

PMA P910030

by Cook, Inc.

Identity

Trade Name
GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) FDA PMA
Generic Name
STENT, CORONARY FDA PMA

Identifiers

PMA Number
P910030 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 Gianturco-Roubin Coronary Flex-Stent is a coronary stent, a tubular metallic device designed to maintain vascular patency in the coronary arteries. It is intended to expand and support the lumen of a narrowed or occluded artery, improving blood flow to the heart muscle by preventing restenosis and promoting long-term vessel stability.

This stent is supplied as a single-use, sterile device and is classified as a Class III medical device under FDA regulations. It is delivered via a catheter-based approach, deployed at the target lesion site, and requires radiographic imaging for proper placement. Authorized under PMA number P910030, it is intended for use in interventional cardiology procedures and adheres to strict manufacturing and quality control standards to ensure safety and efficacy.

Frequently asked questions

What is the Gianturco-Roubin Coronary Flex-Stent™ used for in clinical practice?

This stent is designed to maintain blood flow in coronary arteries by expanding and supporting the lumen of narrowed or occluded vessels. It helps prevent restenosis (re-narrowing of the artery) and promotes long-term vessel stability, which is critical for improving blood supply to the heart muscle during interventional cardiology procedures.

Is the Gianturco-Roubin Coronary Flex-Stent™ intended for single-use or can it be reused?

The device is explicitly supplied as a single-use, sterile stent. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and safety.

How is the Gianturco-Roubin Coronary Flex-Stent™ deployed during a procedure?

The stent is delivered via a catheter-based approach and requires radiographic imaging (such as fluoroscopy) to guide its precise placement at the target lesion site within the coronary artery.

What regulatory pathway was followed for the approval of this device?

The Gianturco-Roubin Coronary Flex-Stent™ was authorized through the FDA’s Premarket Approval (PMA) process, with approval granted under PMA number **P910030**. This pathway is used for high-risk, Class III devices like coronary stents.

Are there multiple sizes or models available for this stent?

While the exact sizes or models aren’t detailed in the provided data, the device is listed under multiple **FEI numbers** (e.g., 3016248656, 3002807091), which typically indicate variations in stent dimensions or configurations. For precise sizing options, refer to the manufacturer’s technical documentation or catalog.

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
Cook, Inc.

Sources (1)

  • FDA PMA P910030 24 fields · synced Sep 18, 2026