| Note: 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. |
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| Device | POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT |
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| Applicant | Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis, MN 55433 |
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| PMA Number | P980017 |
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| Supplement Number | S001 |
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| Date Received | 12/29/1998 |
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| Decision Date | 03/24/1999 |
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| Withdrawal Date | 09/14/2007 |
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| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
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