PMA P170032S007

Device: Woven EndoBridge Aneurysm Embolization (WEB) System
Applicant: MicroVention, Inc.
Product code: OPR
Decision date: 2021-07-16
Generic name: Intrasaccular Flow Disruption Device
Approval order statement: Approval for the change in antioxidants used in the dispenser hoop of packaging of the Flow Re-Direction Endoluminal Device (FRED) System, Woven EndoBridge (WEB) Aneurysm Embolization System and Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. devices.

Current openFDA PMA Record#

Device: Woven EndoBridge Aneurysm Embolization (WEB) System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S007
Product code: OPR
Generic name: Intrasaccular Flow Disruption Device
Decision date: 2021-07-16
Decision code: APPR
Date received: 2021-04-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the change in antioxidants used in the dispenser hoop of packaging of the Flow Re-Direction Endoluminal Device (FRED) System, Woven EndoBridge (WEB) Aneurysm Embolization System and Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. devices.