DiamondBack 360 Coronary Orbital Atherectomy Device (OAD), Orbital Atherectomy System Pump (OAS Pump), ViperWire Advance
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM FDA PMA
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY FDA PMA
Identifiers
- PMA Number
- P130005 FDA PMA
- FDA Product Code
- MCX FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The DiamondBack 360 Coronary Orbital Atherectomy Device is a catheter designed for atherectomy of coronary arteries. It uses an orbital cutting mechanism to ablate calcified plaque within severely stenotic lesions, facilitating subsequent stent delivery in patients with coronary artery disease (CAD). This system is classified as a Class III medical device under the OpenFDA nomenclature for coronary atherectomy catheters.
The device is supplied as a sterile, single-use system comprising the DiamondBack 360 OAD, OAS Pump, and ViperWire Advance guidewire. It is intended for use in catheterization laboratories by trained interventional cardiologists. The system requires FDA_PMA authorization (P130005) and is regulated under the product code MCX. Storage and handling must adhere to sterile medical device protocols to ensure device integrity prior to use.
Frequently asked questions
What is the DiamondBack 360 Coronary Orbital Atherectomy Device primarily used for in clinical practice?
The DiamondBack 360 Coronary Orbital Atherectomy Device is designed to ablate calcified plaque within severely stenotic coronary artery lesions, specifically to facilitate stent delivery in patients with coronary artery disease (CAD). It is intended for use in patients who are candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting, particularly those with de novo, heavily calcified lesions that may otherwise complicate standard intervention.
Is the DiamondBack 360 system single-use or reusable, and how should it be stored?
The DiamondBack 360 system is supplied as a sterile, single-use device, including the DiamondBack 360 OAD, OAS Pump, and ViperWire Advance guidewire. To maintain sterility and device integrity, it must be stored and handled according to standard sterile medical device protocols before use, ensuring no contamination occurs prior to deployment in the catheterization lab.
What regulatory pathway does the DiamondBack 360 Coronary Orbital Atherectomy System follow, and what does this mean for clinicians?
The DiamondBack 360 system follows the FDA Pre-Market Approval (PMA) pathway, authorized under PMA number P130005. This means the device has undergone rigorous clinical evaluation and approval by the FDA to ensure safety and effectiveness for its intended use in facilitating stent delivery in calcified coronary lesions, providing clinicians with confidence in its regulatory standing.
How many different models or sizes of the DiamondBack 360 system are available, and what does this imply for procedural flexibility?
The DiamondBack 360 system includes multiple FEI numbers (e.g., 3011120183, 3021632375, etc.), which correspond to different product variants or sizes. These variations allow clinicians to select the appropriate catheter diameter or length for specific coronary artery anatomies, enhancing procedural flexibility in treating diverse calcified lesion types.
Who is authorized to use the DiamondBack 360 system, and where should it be deployed?
The DiamondBack 360 system is intended for use in catheterization laboratories by trained interventional cardiologists. Its specialized design and orbital cutting mechanism require expertise in coronary interventions, ensuring safe and effective application for patients with severely calcified coronary artery lesions.
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 | P130005 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiovascular Systems, Inc.
Sources (1)
- FDA PMA P130005 24 fields · synced Sep 18, 2026