PMA P170032S002

Device: Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S002
Product code: OPR
Decision date: 2019-10-01
Classification: Intrasaccular Flow Disruption Device
Generic name: Intrasaccular Flow Disruption Device
Approval order statement: Approval for a manufacturing site located at MicroVention Inc. 35 Enterprise, Aliso Viejo, California, for the Woven EndoBridge (WEB) Aneurysm Embolization System.

Current openFDA PMA Record#

Device: Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S002
Product code: OPR
Generic name: Intrasaccular Flow Disruption Device
Decision date: 2019-10-01
Decision code: APPR
Date received: 2019-04-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at MicroVention Inc. 35 Enterprise, Aliso Viejo, California, for the Woven EndoBridge (WEB) Aneurysm Embolization System.