Amplatzer Amulet Left Atrial Appendage Occluder
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Amplatzer Amulet Left Atrial Appendage Occluder FDA PMA
- Generic Name
- System, appendage closure, left atrial FDA PMA
Identifiers
- PMA Number
- P200049 FDA PMA
- FDA Product Code
- NGV FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Amplatzer Amulet Left Atrial Appendage Occluder is a percutaneous transcatheter system designed to reduce the risk of thrombus embolization from the left atrial appendage. It is indicated for patients with nonvalvular atrial fibrillation who are at an increased risk for stroke and systemic embolism.
This device is intended for patients who are suitable for short-term anticoagulation therapy and have a clinical rationale for seeking a non-pharmacologic alternative to oral anticoagulation. The system is manufactured by Abbott Medical and has received FDA PMA approval for use in eligible patients.
Frequently asked questions
What is the primary purpose of the Amplatzer Amulet?
The device is designed to reduce the risk of thrombus embolization originating from the left atrial appendage in patients diagnosed with nonvalvular atrial fibrillation.
Who is a candidate for this device?
Candidates include patients with nonvalvular atrial fibrillation who are at an increased risk for stroke and systemic embolism, are suitable for short-term anticoagulation, and require a non-pharmacologic alternative to oral anticoagulation.
How is the Amplatzer Amulet delivered?
The device is a percutaneous transcatheter system, meaning it is deployed through the skin using a catheter-based procedure to reach the left atrial appendage.
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 | P200049 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P200049 24 fields · synced Sep 18, 2026