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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameJOMED JOSTENT CORONARY STENT GRAFT
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR DEVICES
26531 ynez road
temecula, CA 92591
HDE NumberH000001
Supplement NumberS001
Date Received03/27/2001
Decision Date04/12/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for an alternative sterilization site, medical manufacturing corp. , wholly owned subsidiary of ehtox corp. , erie, pa.
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