PMA P170032S013

Device: Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S013
Product code: OPR
Decision date: 2023-05-22
Classification: Neurology
Generic name: Intrasaccular Flow Disruption Device
Approval order statement: Addition of an alternate supplier of components used for the printed circuit board assembly of the Woven EndoBridge (WEB) Detachment Controller (WDC-2) of the WEB Aneurysm Embolization System.

Current openFDA PMA Record#

Device: Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S013
Product code: OPR
Generic name: Intrasaccular Flow Disruption Device
Decision date: 2023-05-22
Decision code: OK30
Date received: 2023-04-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate supplier of components used for the printed circuit board assembly of the Woven EndoBridge (WEB) Detachment Controller (WDC-2) of the WEB Aneurysm Embolization System.