PMA P180027S011

Device: Flow Re-Direction Endoluminal Device (FRED®) System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S011
Product code: OUT
Decision date: 2024-08-21
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval of the revised 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 P180027/S002

Current openFDA PMA Record#

Device: Flow Re-Direction Endoluminal Device (FRED®) System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S011
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2024-08-21
Decision code: APPR
Date received: 2024-07-22
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 PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180027/S002