7b230160-39e7-43c4-8ac4-6a01785488d3NewPublished12025-06-052025-05-28In Commercial Distribution00850038226206PrimaryGS1InvengenxXM-20111070852Tisgenx, Inc.1falsefalsefalsefalsefalsetruefalsetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK18249300035273Cardiovascular patch, animal-derivedAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.trueActiveFTMMesh, SurgicalHeightLengthStorage Environment Temperaturetruefalse