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.
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.
| Device | POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT |
| Applicant | POSSIS MEDICAL, INC. |
| Date Received | 1998-12-29 |
| Decision Date | 1999-03-24 |
| PMA | P980017 |
| Supplement | S001 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | POSSIS MEDICAL, INC. 9055 Evergreen Blvd., N.w. minneapolis, MN 55433-8003 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980017 | Original Filing | |
| S001 | 1998-12-29 | Normal 180 Day Track |