PMA P170032S011

Device: WEB Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S011
Product code: OPR
Decision date: 2022-01-14
Generic name: Intrasaccular Flow Disruption Device
Approval order statement: Relocation of the supplier of several WEB System components, Creganna Medical, from the manufacturing location in Tualatin, Oregon, to Wilsonville, Oregon.

Current openFDA PMA Record#

Device: WEB Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S011
Product code: OPR
Generic name: Intrasaccular Flow Disruption Device
Decision date: 2022-01-14
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of the supplier of several WEB System components, Creganna Medical, from the manufacturing location in Tualatin, Oregon, to Wilsonville, Oregon.