PMA P980017

Device: POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT
Applicant: Possis Medical, Inc.
PMA number: P980017
Supplement: S001
Decision date: 1999-03-24
Approval order statement: Approval for extending the shelf life of the device from 3 to 6 years, and 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 conditions: 1)central venous cannulation is deemed hazardous or is technically unabailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.

Current openFDA PMA Record#

Device: POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT
Applicant: Possis Medical, Inc.
PMA number: P980017
Supplement: S001
Decision date: 1999-03-24
Decision code: APPR
Date received: 1998-12-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for extending the shelf life of the device from 3 to 6 years, and 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 conditions: 1)central venous cannulation is deemed hazardous or is technically unabailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.