PMA P100018S043

Device: Pipeline™ Vantage Embolization Device with Shield Technology™
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S043
Product code: OUT
Decision date: 2024-06-06
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P100018/S034

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: S043
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2024-06-06
Decision code: APPR
Date received: 2023-10-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P100018/S034