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Volumn 50, Issue 6, 2009, Pages 1459-1461

Premarket assessment of devices for treatment of critical limb ischemia: The role of Objective Performance Criteria and Goals

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOPLASTY; ARTICLE; DEVICE; FOOD AND DRUG ADMINISTRATION; HEART ASSIST DEVICE; LIMB ISCHEMIA; MARKET; MARKETING; METHODOLOGY; POPULATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; SAMPLE SIZE; VALIDITY;

EID: 70649097211     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jvs.2009.10.041     Document Type: Article
Times cited : (19)

References (4)
  • 2
    • 33747349203 scopus 로고    scopus 로고
    • FDA perspective on clinical trial design for cardiovascular devices
    • Chen E., Sapirstein W., Ahn C., Swain J., and Zuckerman B. FDA perspective on clinical trial design for cardiovascular devices. Ann Thorac Surg 82 (2006) 773-775
    • (2006) Ann Thorac Surg , vol.82 , pp. 773-775
    • Chen, E.1    Sapirstein, W.2    Ahn, C.3    Swain, J.4    Zuckerman, B.5
  • 3
    • 33747362048 scopus 로고    scopus 로고
    • Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial
    • Grunkemeier G.L., Jin R., and Starr A. Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial. Ann Thorac Surg 82 (2006) 776-780
    • (2006) Ann Thorac Surg , vol.82 , pp. 776-780
    • Grunkemeier, G.L.1    Jin, R.2    Starr, A.3
  • 4
    • 34249903911 scopus 로고    scopus 로고
    • FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices
    • Goode J., Sapirstein W., and Zuckerman B. FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices. Catheter Cardiovasc Interv 69 (2007) 920-921
    • (2007) Catheter Cardiovasc Interv , vol.69 , pp. 920-921
    • Goode, J.1    Sapirstein, W.2    Zuckerman, B.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.