Woven EndoBridge (WEB) Aneurysm Embolization System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Woven EndoBridge (WEB) Aneurysm Embolization System FDA PMA
- Generic Name
- Intrasaccular Flow Disruption Device FDA PMA
Identifiers
- PMA Number
- P170032 FDA PMA
- FDA Product Code
- OPR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Woven EndoBridge (WEB) Aneurysm Embolization System is an intrasaccular flow disruption device designed for the embolization of saccular intracranial aneurysms. It is intended for use in wide-neck bifurcation aneurysms located in the anterior (middle cerebral artery, internal carotid artery terminus, anterior communicating artery complex) and posterior (basilar apex) circulations, with dome diameters ranging from 3 mm to 10 mm and neck sizes of 4 mm or greater or a dome-to-neck ratio between 1 and 2.
This device is supplied as a single-use, sterile system and is used in neurointerventional procedures under fluoroscopic guidance. It is intended for adult patients only and must be implanted by trained neurointerventionalists in a hospital or clinical setting. The system is regulated under FDA PMA (Premarket Approval) with PMA number P170032, adhering to Class III device standards.
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 | P170032 | Class III | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA PMA P170032 24 fields · synced Sep 18, 2026