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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 NameGRAFTMASTER Coronary Stent Graft System
Classification Namecoronary covered stent
Generic Namecoronary covered stent
Applicant
Abbott Vascular Devices
26531 ynez rd.
temecula, CA 92591
HDE NumberH000001
Supplement NumberS016
Date Received12/11/2017
Decision Date03/05/2018
Product Code
NIV[ Registered Establishments with NIV ]
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 alternate contract sterilizer site located at synergy heath ireland ltd, ida business & technology park, sragh industrial estate, tullamore, co. Offaly, ireland. To perform as an alternate ethylene oxide sterilization vendor for the graftmaster coronary stent graft system (h000001/s016), multi-link 8 coronary, 8 ll coronary, and 8 sv coronary stent system (p020047/s067), xience v and nano everolimus eluting coronary stent system (p070015/s139), and xience prime/xpedition/alpine/sierra everolimus eluting coronary stent system (sv, ll) (p110019/s096).
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