PMA P170032S012

Device: Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S012
Product code: OPR
Decision date: 2024-02-05
Classification: Neurology
Generic name: Intrasaccular Flow Disruption Device
Approval order statement: approval for labeling changes to incorporate the completed results (through 5 years postoperative) from the post-approval study (PAS) titled “WEB-IT Study”.

Current openFDA PMA Record#

Device: Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S012
Product code: OPR
Generic name: Intrasaccular Flow Disruption Device
Decision date: 2024-02-05
Decision code: APPR
Date received: 2023-03-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for labeling changes to incorporate the completed results (through 5 years postoperative) from the post-approval study (PAS) titled “WEB-IT Study”.