Simpson Coronary Atherectomy Catheter
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- SIMPSON CORONARY ATHEROCATH(TM) FDA PMA
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY FDA PMA
Identifiers
- PMA Number
- P890043 FDA PMA
- FDA Product Code
- MCX FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Simpson Coronary Atherectomy Catheter is a coronary atherectomy catheter, designed for the mechanical removal of atherosclerotic plaque from coronary arteries. It operates through a cutting mechanism to excise calcified and obstructive lesions, restoring luminal patency in patients with significant coronary artery disease.
This device is supplied as a single-use, sterile instrument and is intended for use in cardiac catheterization laboratories under fluoroscopic guidance. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA) application. Multiple model variants are available, each with distinct specifications for compatibility with different coronary artery diameters and lesion types.
Frequently asked questions
What types of coronary artery blockages is the Simpson Coronary Atherectomy Catheter specifically designed to treat?
The Simpson Coronary Atherectomy Catheter is engineered to mechanically remove atherosclerotic plaque, particularly calcified and obstructive lesions, within coronary arteries. It is intended for use in patients with significant coronary artery disease where luminal patency needs to be restored through the excision of hardened plaque. The device’s cutting mechanism is optimized for these challenging lesion types.
How many model variants of the Simpson Coronary Atherectomy Catheter are available, and what determines their compatibility with different coronary arteries?
Multiple model variants of the Simpson Coronary Atherectomy Catheter are available, each designed to match specific coronary artery diameters and lesion characteristics. The distinct specifications for these variants ensure compatibility with a range of anatomical and pathological conditions, allowing clinicians to select the appropriate size and type for their patient’s needs.
Is the Simpson Coronary Atherectomy Catheter intended for reuse, or is it designed for single-use only?
The Simpson Coronary Atherectomy Catheter is explicitly supplied as a single-use, sterile instrument. This design ensures patient safety and maintains device performance, as reuse could compromise sterility and integrity after a single procedure.
What procedural setting is the Simpson Coronary Atherectomy Catheter intended for, and how is its use guided?
The device is intended for use exclusively in cardiac catheterization laboratories under fluoroscopic guidance. Fluoroscopy allows real-time visualization of the coronary arteries and the catheter’s placement, ensuring precise and safe removal of obstructive plaque during the procedure.
What regulatory pathway was followed for the approval of the Simpson Coronary Atherectomy Catheter, and what does this mean for its use?
The Simpson Coronary Atherectomy Catheter underwent a Premarket Approval (PMA) process, which is the FDA’s most stringent review for high-risk medical devices like Class III catheters. This pathway ensures rigorous evaluation of safety and effectiveness before the device can be marketed, providing confidence in its clinical application for mechanical plaque removal in coronary arteries.
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 | P890043 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA PMA P890043 24 fields · synced Sep 18, 2026