PMA P170032S022

Device
Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant
MicroVention, Inc.
PMA number
P170032
Supplement
S022
Product code
OPR
Decision date
2026-05-28
Classification
Neurology
Generic name
Intrasaccular Flow Disruption Device
Approval order statement
approval for a change in supplier of the connector component from Cregana Wilsonville to Medway

Current openFDA PMA Record#

Device
Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant
MicroVention, Inc.
PMA number
P170032
Supplement
S022
Product code
OPR
Generic name
Intrasaccular Flow Disruption Device
Decision date
2026-05-28
Decision code
OK30
Date received
2026-05-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for a change in supplier of the connector component from Cregana Wilsonville to Medway