Cheatham Platinum CP Stent System

FDA PMA

Class III (US FDA PMA)

PMA P150028

by NuMED, Inc.

Identity

Trade Name: CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) FDA PMA
Generic Name: Aortic stent FDA PMA

Identifiers

PMA Number: P150028 FDA PMA
FDA Product Code: PNF FDA PMA
Models / Variants: Covered CP Stent FDA PMA
Covered Mounted CP Stent FDA PMA
CP Stent FDA PMA
Mounted CP Stent FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA

The Cheatham Platinum CP Stent System is an aortic stent designed for the treatment of native and recurrent coarctation of the aorta. The system includes the CP Stent, Mounted CP Stent, Covered CP Stent, and Covered Mounted CP Stent, which are used when balloon angioplasty is contraindicated or predicted to be ineffective.

These stents are indicated for use in the aortic isthmus or the first segment of the descending aorta, provided there is adequate size and patency of at least one femoral artery. The covered versions are specifically indicated for cases involving aortic wall injury, nearly atretic descending aorta, non-compliant stenotic segments, or genetic syndromes associated with aortic wall weakening. This device is manufactured by NuMED, Inc. and has received FDA PMA approval.

Frequently asked questions

What is the Cheatham Platinum CP Stent System used for?

The system is indicated for the treatment of native and recurrent coarctation of the aorta in the aortic isthmus or the first segment of the descending aorta where balloon angioplasty is not suitable.

What is the difference between the CP Stent and the Covered CP Stent?

The Covered CP Stent and Covered Mounted CP Stent are indicated for more complex cases, such as acute or chronic aortic wall injury, nearly atretic descending aorta, non-compliant stenotic segments, or conditions associated with aortic wall weakening.

Are there specific anatomical requirements for using this stent?

Yes, the procedure requires that there is adequate size and patency of at least one femoral artery to allow for the delivery of the stent system.

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. Sources consulted: The CP stent—short, long, covered—for the treatment of aortic ..., Covered CP Stent™ - B. Braun Interventional Systems, [PDF] summary of safety and effectiveness data (ssed), B. Braun Will Distribute NuMed's Newly Approved Cheatham ..., Stents | NuMED For Children

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Pending data

MDD

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	European Union	MDD	—	Class III	Pending data
FDA PMA	United States	FDA_PMA	P150028	Class III	Active

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Manufacturer

Manufacturer: NuMED, Inc.

Sources (1)

FDA PMA P150028 24 fields · synced Oct 6, 2026