PMA P170032S017

Device: Woven EndoBridge Aneurysm Embolization (WEB) System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S017
Product code: OPR
Decision date: 2024-09-23
Classification: Neurology
Generic name: Intrasaccular Flow Disruption Device
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The revised PAS protocol has been submitted to comply with the conditions of approval outlined in our December 31, 2018, approval order for P170032

Current openFDA PMA Record#

Device: Woven EndoBridge Aneurysm Embolization (WEB) System
Applicant: MicroVention, Inc.
PMA number: P170032
Supplement: S017
Product code: OPR
Generic name: Intrasaccular Flow Disruption Device
Decision date: 2024-09-23
Decision code: APPR
Date received: 2024-08-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The revised PAS protocol has been submitted to comply with the conditions of approval outlined in our December 31, 2018, approval order for P170032