This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
The addition of braiding and furnace equipment for the fred implant at the microvention costa rica facility
|Device||Flow Re-Direction Endoluminal (FRED) System|
|Generic Name||Intracranial Aneurysm Flow Diverter|
|Supplement Type||30-day Notice|
|Supplement Reason||Process Change - Manufacturer/sterilizer/packager/supplier|
|Applicant Address||MicroVention Terumo 35 Enterpricse aliso Viejo, CA 92765|
|Supplement Number||Date||Supplement Type|