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. |
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Trade Name | GRAFTMASTER Coronary Stent Graft System |
Classification Name | coronary covered stent |
Generic Name | coronary covered stent |
Applicant |
ABBOTT VASCULAR DEVICES |
26531 ynez road |
temecula, CA 92591 |
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HDE Number | H000001 |
Supplement Number | S016 |
Date Received | 12/11/2017 |
Decision Date | 03/05/2018 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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