FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intrasaccular Flow Disruption Device
PMA: P170032
·
Supplement: S009
·
Decision Oct 14, 2021
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
- S009
- 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
- October 14, 2021
- Date Received
- July 26, 2021
- Supplement Type
- Real-Time Process
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for electron beam (E-beam) radiation as an additional sterilization method for 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 |