LEGOO Temporary Endovascular Occluder
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- LEGOO FDA PMA
- Generic Name
- Occluder, internal vessel, temporary FDA PMA
Identifiers
- PMA Number
- P110003 FDA PMA
- FDA Product Code
- OBC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The LEGOO Temporary Endovascular Occluder is a Class III device classified as an internal vessel occluder designed for temporary occlusion of blood vessels below the neck. It is intended for use in vessels up to 4 mm in diameter, providing controlled vascular closure during interventional procedures.
This device is supplied sterile and is intended for single-use. It is regulated under an FDA Premarket Approval (PMA) with approval number P110003, filed under product code OBC for cardiovascular applications. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Frequently asked questions
What types of blood vessels is the LEGOO Temporary Endovascular Occluder designed to temporarily close, and what size vessels can it handle?
The LEGOO is specifically designed for temporary occlusion of blood vessels located below the neck. It is intended for use in vessels with a diameter up to 4 mm, providing controlled closure during interventional procedures.
Is the LEGOO Temporary Endovascular Occluder meant for repeated use, or is it single-use only?
The LEGOO is supplied sterile and explicitly intended for single-use only. This ensures patient safety and maintains device integrity, as reuse could compromise sterility and performance.
How should the LEGOO Temporary Endovascular Occluder be stored to maintain its sterility and functionality?
The LEGOO must be stored and handled according to sterile medical device protocols to preserve its integrity before use. This includes keeping it in its original packaging and following manufacturer guidelines to prevent contamination.
What regulatory pathway does the LEGOO Temporary Endovascular Occluder follow, and what approval number is associated with it?
The LEGOO follows the FDA Premarket Approval (PMA) pathway, which is required for Class III devices. It holds approval number P110003, filed under product code OBC for cardiovascular applications, reflecting its classification as an internal vessel occluder.
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 | P110003 | Class III | Active |
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Manufacturer
- Manufacturer
- Genzyme Corp.
Sources (1)
- FDA PMA P110003 24 fields · synced Sep 18, 2026