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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NamePERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20
Generic Namevascular graft prosthesis of 6mm and greater diameter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980017
Date Received12/12/1997
Decision Date09/25/1998
Withdrawal Date 09/14/2007
Docket Number 98M-0835
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
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 
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