FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intrasaccular Flow Disruption Device
PMA: P170032
·
Supplement: S014
·
Decision Nov 24, 2023
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Intrasaccular Flow Disruption Device
- Trade Name
- Woven EndoBridge (WEB) Aneurysm Embolization System
- PMA Number
- P170032
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- OPR
- Generic Name
- Intrasaccular Flow Disruption Device
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 24, 2023
- Date Received
- August 3, 2023
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
approval for the tether diameter and manufacturing process change for the W5 models of the Woven EndoBridge (WEB) Aneurysm Embolization System
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OPR | Intrasaccular Flow Disruption Device | FDA class 3 | Unknown |