PMA P180027S001
- Device
- Flow Re-Direction Endoluminal Device (FRED) System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S001
- Product code
- OUT
- Decision date
- 2020-07-17
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Addition of braiding and furnace equipment for the FRED implant at the MicroVention Costa Rica facility.
Current openFDA PMA Record#
- Device
- Flow Re-Direction Endoluminal Device (FRED) System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S001
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-07-17
- Decision code
- OK30
- Date received
- 2020-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of braiding and furnace equipment for the FRED implant at the MicroVention Costa Rica facility.