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.
Conversion of a two-step uv glue process into a 1-step uv glue process for the flow re-direction endoluminal device (fred) system
|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, Inc. 35 Enterpricse aliso Viejo, CA 92656|
|Supplement Number||Date||Supplement Type|