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Humanitarian Use Device | 合法醫療器材資訊網

Humanitarian Use Device

Specifically,thestenthasbeenapprovedforuseinthetreatmentofperforations(​tears)inavesselwall(anativevesselorveinbypassgraft)thatcancauseblood​ ...

 Humanitarian Use Device

Title   Abbott GRAFTMASTER® RX Coronary Stent Graft System, humanitarian use device Description  

The FDA has approved the Abbott GRAFTMASTER® RX Coronary Stent Graft System for commercial use in selected patients under a Humanitarian Device Exemption (HDE). Specifically,  the stent has been approved for use in the treatment of perforations (tears) in a vessel wall (a native vessel or vein bypass graft) that can cause blood to leak into the lining of the heart.

HDE Number   H000001 Notes  

Percutaneous Coronary Interventions such as angioplasty, stent, or athrectomy procedures are treatments used to restor...

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GRAFTMASTER RX Coronary Stent Graft System | 合法醫療器材資訊網
The GRAFTMASTER RX Coronary Stent Graft System is designed to treat free perforations in native coronary vessels or saphenous vein bypass grafts. Read More
Graftmaster Rx Coronary Stent Graft System | 合法醫療器材資訊網
GRAFTMASTER RX Coronary Stent Graft System. HUMANITARIAN USE DEVICE: CORONARY INTERVENTION. FAMILY AND CATEGORY: HUMANITARIAN ... Read More
藥物資訊 | 合法醫療器材資訊網
2014年10月3日 — 英文品名, “Abbott”GraftMaster RX Coronary Stent Graft System, 主類別二 ... 效能(​適應症), GRAFTMASTER RX冠狀動脈包覆支架是氣球擴張的預 ... Read More
Humanitarian Use Device | 合法醫療器材資訊網
Specifically, the stent has been approved for use in the treatment of perforations (​tears) in a vessel wall (a native vessel or vein bypass graft) that can cause blood​ ... Read More
Vascular Intervention Coronary Covered Coronary Stent ... | 合法醫療器材資訊網
1.63 mm. 1.25 mm. 23% reduction in diameter1. PK Papyrus. 3.0/15. BIOTRONIK. Jostent. Graftmaster. 3.0/162. Bending stiffness of crimped stent (N/mm2). 0. Read More
Humanitarian Device Exemption (HDE) | 合法醫療器材資訊網
Be sure to look at the original HDE23 to get an up-to-date view of this device. Trade Name, GRAFT MASTER RX CORONARY STENT GRAFT SYSTM. Read More
JOSTEN Coronary Stent Graft INSTRUCTIONS FOR USE ... | 合法醫療器材資訊網
The JOSTENT9 Coronary Stent Graft System includes: Two high-grade surgical steel flexible stents, manufactured from a solid tube using precision laser ... Read More
MAUDE Adverse Event Report | 合法醫療器材資訊網
Two additional 3. 5x19 graftmaster stents (9112841, 9032941) were implanted, one proximal and one distal to the implanted 3. 5x16mm graftmaster stent, but the​ ... Read More
Coronary Perforation and Covered Stents | 合法醫療器材資訊網
由 M Al-Mukhaini 著作 · 2011 · 被引用 60 次 — Keywords: Cardiac tamponade, coronary perforation, covered stent ... use of a rapid exchange covered stent (JOSTENT GraftMaster [Abbot vascular Inc.] 3 × 16​ ... Read More
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