PMA P180027S008

Device: Flow Re-Direction Endoluminal Device (FRED) and FRED X System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S008
Product code: OUT
Decision date: 2022-03-25
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Relocation of existing equipment used for inner stent braiding and heat setting for Flow Re-Direction Endoluminal Device (FRED) System and FRED X System to a new building at the existing Costa Rica manufacturing facility.

Current openFDA PMA Record#

Device: Flow Re-Direction Endoluminal Device (FRED) and FRED X System
Applicant: MicroVention, Inc.
PMA number: P180027
Supplement: S008
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2022-03-25
Decision code: OK30
Date received: 2022-03-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of existing equipment used for inner stent braiding and heat setting for Flow Re-Direction Endoluminal Device (FRED) System and FRED X System to a new building at the existing Costa Rica manufacturing facility.