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Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter

FDA PMA

Class III (US FDA PMA)

PMA P210039

by Trireme Medical, Llc

Identity

Trade Name
Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) FDA PMA
Generic Name
Drug-Eluting Peripheral Transluminal Angioplasty Catheter FDA PMA

Identifiers

PMA Number
P210039 FDA PMA
FDA Product Code
ONU FDA PMA

Classification

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

The Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter is a drug-eluting peripheral transluminal angioplasty catheter indicated for percutaneous transluminal angioplasty after appropriate vessel preparation. It is used to treat de novo or restenotic lesions up to 180 mm in length in native femoral or popliteal arteries with reference vessel diameters of 4.0 mm to 6.0 mm.

Supplied sterile and intended for single-use, the device is manufactured by Trireme Medical, LLC and holds FDA PMA approval (P210039). It is designed for use in cardiovascular interventional procedures and is not MRI conditional unless explicitly stated in labeling.

Frequently asked questions

What is the Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter used for?

It is indicated for percutaneous transluminal angioplasty after appropriate vessel preparation of de novo or restenotic lesions up to 180 mm in length in native femoral or popliteal arteries with reference vessel diameters of 4.0 mm to 6.0 mm, as stated in the approval documentation.

Is the Chocolate Touch catheter reusable or single-use?

The device is supplied sterile and intended for single-use only, as is standard for percutaneous transluminal angioplasty catheters to prevent cross-contamination and ensure drug coating integrity.

What regulatory authorization does the Chocolate Touch catheter have?

The device has received FDA Premarket Approval (PMA) under number P210039, which was granted on November 4, 2022, following review of its safety and effectiveness for the indicated use.

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
Trireme Medical, Llc

Sources (1)

  • FDA PMA P210039 24 fields · synced Sep 18, 2026