Presillion Plus CoCr Coronary Stent on RX System
FDA PMAClass III (US FDA PMA)
by Medinol Ltd.
Identity
- Trade Name
- PRESILLION PLUS COCR CORONARY STENT RX SYSTEM FDA PMA
- Generic Name
- STENT, CORONARY FDA PMA
Identifiers
- PMA Number
- P110004 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 Presillion Plus CoCr Coronary Stent on RX System is a Stent, Coronary (per nomenclature authority), designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease. It is intended for use in de novo native coronary arteries with stenotic lesions, limited to lengths of 30 mm or less and reference vessel diameters between 2.50 mm and 4.00 mm.
This device is supplied as a reusable delivery system with a cobalt-chromium (CoCr) stent and is approved under FDA_PMA (PMA Number: P110004). It is classified as a Class III medical device and intended for single-use in interventional cardiology settings. Storage and handling must comply with sterile medical device protocols, as per regulatory requirements.
Frequently asked questions
What specific coronary artery conditions is this stent designed to treat, and what are the key size limitations for use?
This device is designed to improve the coronary luminal diameter in patients with symptomatic ischemic heart disease caused by stenotic lesions in de novo native coronary arteries. It is intended for lesions up to 30 millimeters in length and reference vessel diameters between 2.50 mm and 4.00 mm. The stent is not intended for use in other types of lesions, such as chronic total occlusions or bifurcation lesions.
Is the delivery system for this stent reusable or single-use, and how should it be handled to maintain sterility?
The Presillion Plus CoCr Coronary Stent on RX System is intended for single-use in interventional cardiology settings. Since it is a medical device, it must be handled and stored according to sterile medical device protocols to ensure patient safety and prevent contamination. The reusable aspect refers to the delivery system’s design, but the stent itself is not meant for reuse.
What regulatory pathway was followed for this device’s approval, and what class does it fall under?
This device was approved under the FDA’s Premarket Approval (PMA) pathway, specifically under PMA Number P110004. It is classified as a Class III medical device, which typically requires rigorous pre-market approval due to its higher risk profile and intended use in critical procedures like coronary stenting.
Are there multiple sizes or models available for this stent system, and how would a clinician determine the appropriate size for a patient?
While the data does not explicitly list individual stent diameters or models, the device is designed for reference vessel diameters between 2.50 mm and 4.00 mm. Clinicians would select the appropriate size based on the patient’s coronary artery dimensions, ensuring compatibility with the specified length limit of 30 mm or less. The delivery system is tailored to deploy stents within this range, so precise sizing would rely on pre-procedure imaging and measurement.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110004 | Class III | Active |
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Manufacturer
- Manufacturer
- Medinol Ltd.
- FDA Applicant
- Medinol, Ltd.
Sources (1)
- FDA PMA P110004 24 fields · synced Sep 18, 2026