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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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 NameJOMED JOSTENT CORONARY STENT GRAFT
Classification Namecoronary covered stent
Generic Namecoronary covered stent
Applicant
ABBOTT VASCULAR DEVICES
26531 ynez road
temecula, CA 92591
HDE NumberH000001
Date Received02/07/2000
Decision Date01/10/2001
Product Code
NIV[ Registered Establishments with NIV ]
Docket Number 01M-0062
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
This device is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts >/= 2. 75 mm in diameter.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 
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