Identity
- Trade Name
- AIS EXIMER LASER ANGIOPLASTY FDA PMA
- Generic Name
- DEVICE, ANGIOPLASTY, LASER, CORONARY FDA PMA
Identifiers
- PMA Number
- P900032 FDA PMA
- FDA Product Code
- LPC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The AIS Excimer Laser Angioplasty System is a Class III coronary angioplasty laser device, designed for the removal of atherosclerotic plaque within coronary arteries. It employs excimer laser technology to vaporise obstructive lesions, restoring blood flow in patients with coronary artery disease.
This device is supplied as a reusable system and is intended for use in clinical settings such as cardiac catheterisation laboratories. It requires sterile handling and is regulated under an FDA Premarket Approval (PMA) with PMA number P900032. The system is categorised under product code LPC and is authorised for use in coronary artery interventions.
Frequently asked questions
What clinical procedure is the AIS Excimer Laser Angioplasty System intended to assist with, and how does it work?
The AIS Excimer Laser Angioplasty System is designed to remove atherosclerotic plaque from coronary arteries, improving blood flow in patients with coronary artery disease. It uses excimer laser technology to vaporize obstructive lesions, effectively clearing blockages within the arteries. This procedure is typically performed in cardiac catheterization labs as part of coronary artery interventions.
Is the AIS Excimer Laser Angioplasty System reusable, and what precautions should be taken during use?
Yes, the AIS Excimer Laser Angioplasty System is supplied as a reusable device, meaning it is intended for repeated use in clinical settings. Since it requires sterile handling during each procedure, proper sterilization protocols must be followed between uses to ensure patient safety and device efficacy.
What regulatory pathway was followed for the approval of this device, and what does that mean for its use?
The AIS Excimer Laser Angioplasty System was approved through the FDA’s Premarket Approval (PMA) process, with PMA number **P900032**. This means the device underwent rigorous scientific and clinical evaluation to ensure its safety and effectiveness for its intended use in coronary artery interventions, as outlined in the PMA filing.
What product code and advisory committee category does this device fall under in regulatory filings?
The AIS Excimer Laser Angioplasty System is categorized under **product code LPC** in regulatory filings, which corresponds to coronary angioplasty devices. It was reviewed by the **Cardiovascular (CV) Advisory Committee**, reflecting its specialized use in cardiovascular interventions.
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 | P900032 | Class III | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corp.
Sources (1)
- FDA PMA P900032 24 fields · synced Sep 18, 2026