메뉴 건너뛰기




Volumn 9, Issue 1, 2006, Pages 123-127

Mechanical Devices and US Food and Drug Administration (FDA) Approval

Author keywords

pediatric cardiac surgery; regulatory process; Ventricular assist device

Indexed keywords

ARTICLE; BLOOD PUMP; COST BENEFIT ANALYSIS; DONOR; EUROPE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEART ASSIST DEVICE; HEART TRANSPLANTATION; HUMAN; LONG TERM CARE; PEDIATRICS; PNEUMATIC TOOL; SAFETY; SURGEON; UNITED STATES; CHILD; CONGESTIVE HEART FAILURE; EQUIPMENT DESIGN; GOVERNMENT REGULATION; INFANT; REVIEW;

EID: 33645903552     PISSN: 10929126     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.pcsu.2006.02.018     Document Type: Article
Times cited : (8)

References (13)
  • 1
    • 11144354554 scopus 로고    scopus 로고
    • Cardiac ECMO for biventricular hearts after paediatric open heart surgery
    • Chaturvedi R.R., Macrae D., Brown K.L., et al. Cardiac ECMO for biventricular hearts after paediatric open heart surgery. Heart 90 (2004) 545-551
    • (2004) Heart , vol.90 , pp. 545-551
    • Chaturvedi, R.R.1    Macrae, D.2    Brown, K.L.3
  • 2
    • 0032979259 scopus 로고    scopus 로고
    • Mechanical circulatory support in children with cardiac disease
    • Duncan B.W., Hraska V., Jonas R.A., et al. Mechanical circulatory support in children with cardiac disease. J Thorac Cardiovasc Surg 117 (1999) 529-542
    • (1999) J Thorac Cardiovasc Surg , vol.117 , pp. 529-542
    • Duncan, B.W.1    Hraska, V.2    Jonas, R.A.3
  • 3
    • 33645915665 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US Food and Drug Administration: Available at: http://www.fda.gov/ (accessed February 27, 2006)
  • 4
    • 33645956987 scopus 로고    scopus 로고
    • European Medicines Agency: Available at: http://www.emea.eu.int/ (accessed February 27, 2006)
  • 5
    • 33645899201 scopus 로고    scopus 로고
    • European Medicines Agency: Active implantable medical devices directive. Available at: http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/implmedd.html (accessed March 9, 2006)
  • 6
    • 33645908078 scopus 로고    scopus 로고
    • Global Harmonization Task Force: Available at: http://www.ghtf.org/information/information.htm (accessed February 27, 2006)
  • 7
    • 33645942626 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US Food and Drug Administration: Humanitarian use device regulations. Available at: http://www.fda.gov/orphan/humuse.htm (accessed February 27, 2006)
  • 8
    • 0035892018 scopus 로고    scopus 로고
    • Long-term use of a left ventricular assist device for end-stage heart failure
    • Rose E.A., Gelijns A.C., Moskowitz A.J., et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 345 (2001) 1435-1443
    • (2001) N Engl J Med , vol.345 , pp. 1435-1443
    • Rose, E.A.1    Gelijns, A.C.2    Moskowitz, A.J.3
  • 9
    • 23744450439 scopus 로고    scopus 로고
    • Registry of the International Society for Heart and Lung Transplantation. Eighth official pediatric report - 2005
    • Boucek M.M., Edwards L.B., Keck B.M., et al. Registry of the International Society for Heart and Lung Transplantation. Eighth official pediatric report - 2005. J Heart Lung Transpl 24 (2005) 968-982
    • (2005) J Heart Lung Transpl , vol.24 , pp. 968-982
    • Boucek, M.M.1    Edwards, L.B.2    Keck, B.M.3
  • 10
    • 26444606968 scopus 로고    scopus 로고
    • The first successful DeBakey VAD Child implantation as a bridge to transplant
    • Imamura M., Hale S., Johnson C.E., et al. The first successful DeBakey VAD Child implantation as a bridge to transplant. ASAIO J 51 (2005) 670-672
    • (2005) ASAIO J , vol.51 , pp. 670-672
    • Imamura, M.1    Hale, S.2    Johnson, C.E.3
  • 11
    • 22544457916 scopus 로고    scopus 로고
    • Pneumatic pulsatile ventricular assist devices in children under 1 year of age
    • Stiller B., Hubler M., Lemmer J., et al. Pneumatic pulsatile ventricular assist devices in children under 1 year of age. Eur J Cardiothorac Surg 28 (2005) 234-239
    • (2005) Eur J Cardiothorac Surg , vol.28 , pp. 234-239
    • Stiller, B.1    Hubler, M.2    Lemmer, J.3
  • 13
    • 33645955814 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US Food and Drug Administration: Best pharmaceuticals for children act. Available at: http://www.fda.gov/opacom/laws/pharmkids/contents.html (accessed February 27, 2006)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.