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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NamePERMA-FLOW CORONARY GRAFT MODEL 2C10
Classification Namegraft, bypass, coronary artery
Generic Namegraft, bypass, coronary artery
Applicant
POSSIS MEDICAL, INC.
9055 evergreen blvd., n.w.
minneapolis, MN 55433-8003
HDE NumberH970005
Date Received11/04/1997
Decision Date04/30/1998
Product Code
NAV[ Registered Establishments with NAV ]
Docket Number 98M-0452
Advisory Committee Cardiovascular
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the perma-flowo coronary graft, model 2c10. This device is indicated for single or multiple vessel coronary artery bypass in patients who are receiving coronary bypass grafting but who have inadequate autologous conduit to complete the required revascularization.
Approval OrderApproval Order
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