PMA P170032S010

Device: (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S010
Product code: OPR
Decision date: 2021-12-20
Generic name: Intrasaccular Flow Disruption Device
Approval order statement: Change in bacterial endotoxin test sampling plan and to update the manufacturing procedure to conduct bacterial endotoxin testing prior to device sterilization.

Current openFDA PMA Record#

Device: (WEB) Aneurysm Embolization System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S010
Product code: OPR
Generic name: Intrasaccular Flow Disruption Device
Decision date: 2021-12-20
Decision code: OK30
Date received: 2021-11-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in bacterial endotoxin test sampling plan and to update the manufacturing procedure to conduct bacterial endotoxin testing prior to device sterilization.