| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 |
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| Applicant | POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 |
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| PMA Number | P980017 |
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| Date Received | 12/12/1997 |
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| Decision Date | 09/25/1998 |
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Withdrawal Date
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09/14/2007 |
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| Docket Number | 98M-0835 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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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. |
| Supplements: |
S001 |
|
|
