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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 GRAFT MASTER
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
Abbott Vascular Devices
26531 ynez rd.
temecula, CA 92591
HDE NumberH000001
Supplement NumberS003
Date Received09/25/2001
Decision Date03/18/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the over-the-wire delivery system, the 11, 14, 18, and 29 mm length jostent graft master for the jostent coronary stent graft; the addition of a new manufacturing facility, jomed, inc. , 15330 avenue of science, suite 200, san diego, california; the addition of a new contractsterilizer, griffith micro science/iba, 4900 south gifford avenue, losangeles, california, and removal of the formal on-site training requirement.
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