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.
Pad printed component supplier change.
|Device||Tack Endovascular System (4F)|
|Generic Name||Scaffold, Dissection Repair|
|Applicant||Intact Vascular, Inc.|
|Supplement Type||30-day Notice|
|Supplement Reason||Process Change - Manufacturer/sterilizer/packager/supplier|
|Applicant Address||Intact Vascular, Inc. 1285 Drummers Lane, #200 wayne, PA 19087|
|Supplement Number||Date||Supplement Type|