PMA P100018S017

Device: Pipeline Flex Embolization Device (PFED)
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S017
Product code: OUT
Decision date: 2018-06-15
Classification: Intracranial Aneurysm Flow Diverter
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Approval for modifications to the device labeling to include a summary of the long-term follow-up results of the Pipeline for Uncoilable or Failed Aneurysms - Post Approval Study (PUFS-PAS).

Current openFDA PMA Record#

Device: Pipeline Flex Embolization Device (PFED)
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S017
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2018-06-15
Decision code: APPR
Date received: 2017-12-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the device labeling to include a summary of the long-term follow-up results of the Pipeline for Uncoilable or Failed Aneurysms - Post Approval Study (PUFS-PAS).