PMA P180027S003

Device: Flow Re-Direction Endoluminal Device (FRED®) System
Applicant: MicroVention, Inc.
Product code: OUT
Decision date: 2021-07-16
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Approval for a change in antioxidants used in the dispenser hoop of packaging of the FRED System, WEB Aneurysm Embolization System and LVIS and LVIS Jr.

Current openFDA PMA Record#

Device: Flow Re-Direction Endoluminal Device (FRED®) System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S003
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2021-07-16
Decision code: APPR
Date received: 2021-04-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in antioxidants used in the dispenser hoop of packaging of the FRED System, WEB Aneurysm Embolization System and LVIS and LVIS Jr.