PMA P100018S048

Device: Pipeline™ Vantage Embolization Device with Shield Technology™
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S048
Product code: OUT
Decision date: 2025-08-14
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Approval for changes to the post-approval study (PAS) protocol for Pipeline Vantage device following the removal of the Vantage 027 devices, including updates to include additional follow-up imaging to assess for braid deformation events.

Current openFDA PMA Record#

Device: Pipeline™ Vantage Embolization Device with Shield Technology™
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S048
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2025-08-14
Decision code: APPR
Date received: 2025-01-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval for changes to the post-approval study (PAS) protocol for Pipeline Vantage device following the removal of the Vantage 027 devices, including updates to include additional follow-up imaging to assess for braid deformation events.