|Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.|
|Trade Name||PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20|
|Generic Name||vascular graft prosthesis of 6mm and greater diameter|
|Applicant||POSSIS MEDICAL, INC.|
|Docket Number|| 98M-0835|
|Expedited Review Granted?|| Yes|
|Approval Order Statement |
Approval for the possis perma-seal(r) dialysis access graft, model 2c20-b. This device is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditons: 1) central venous cannulation is deemed hazardous or is technically unavailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.