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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 NameJOSONICS GRAFTMASTER
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR DEVICES
26531 ynez road
temecula, CA 92591
HDE NumberH000001
Supplement NumberS005
Date Received04/27/2004
Decision Date05/19/2004
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 01M-0062
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 approval for a new assembly and packaging site, abbott vascular instruments deutschland gmbh, located at rudolph diesel stra~e 29, rangendingen, germany, and a new sterilization site, sterigenics, located at dreiceistrasse 7, mdhirdelden, germany.
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