SCOPUS 정보 검색 플랫폼

Circulation

Volumn 112, Issue 18, 2005, Pages 2883-2886

Humanitarian use devices/humanitarian device exemptions in cardiovascular medicine

(6) Kaplan, Aaron V a Harvey, Elisa D b Kuntz, Richard E c Shiran, Hadas a Robb, John F a Fitzgerald, Peter d

a DARTMOUTH HITCHCOCK MEDICAL CENTER (United States)

b CENTER FOR DRUG EVALUATION AND RESEARCH (United States)

c BRIGHAM AND WOMEN S HOSPITAL (United States)

d STANFORD UNIVERSITY (United States)

Author keywords

Catheter; Catheterization; Heart disease; Surgery

Indexed keywords

CARDIOVASCULAR DISEASE; CATHETERIZATION; CONFERENCE PAPER; CONSENSUS; DEVICE; DIAGNOSTIC TEST; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HEART DISEASE; HEART SURGERY; HUMAN; HUMANITARIAN DEVICE EXEMPTION; HUMANITARIAN USE DEVICE; MARKET; MEDICAL INSTRUMENTATION; PRIORITY JOURNAL; SAFETY; TREATMENT INDICATION;

ALTRUISM; CARDIOLOGY; CARDIOVASCULAR DISEASES; DEVICE APPROVAL; HEART CATHETERIZATION; HEART DISEASES; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 27844611541 PISSN: 00097322 EISSN: None Source Type: Journal
DOI: 10.1161/CIRCULATIONAHA.105.553701 Document Type: Conference Paper

Times cited : (11)

References (12)

1
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- Kaplan, A.V.¹ Baim, D.S.² Smith, J.J.³ Feigal, D.A.⁴ Simons, M.S.⁵ Jefferys, D.⁶ Fogarty, T.J.⁷ Kuntz, R.E.⁸ Leon, M.B.⁹

2
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- Post Safe Medical Devices Act (SMDA) of 1990. Public Law 91-4243
- Post Safe Medical Devices Act (SMDA) of 1990. Public Law 91-4243.

3
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- 21 CFR 814. subpart H
- 21 CFR 814. subpart H.

4
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- Fetal stent receives first "humanitarian use" approval
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- (1997) HHS News
- Snider, S.¹

5
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- Section 520(m), Food. Drug and Cosmetic Act
- Section 520(m), Food. Drug and Cosmetic Act.

6
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- Rockville, Md: Centers for Devices and Radiologic Health, US Food and Drug Administration: July 12
- Humanitarian Device Exemption (HDE) Regulation: Questions and Answers: Final Guidance for Industry. Rockville, Md: Centers for Devices and Radiologic Health, US Food and Drug Administration: July 12, 2001.
- (2001) Humanitarian Device Exemption (HDE) Regulation: Questions and Answers: Final Guidance for Industry

7
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8
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- (2003) Annual Report , pp. 16

9
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10
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- First Food and Drug Administration approval under Humanitarian Device Exemption of a septal occluder for fenestrated fontan and muscular ventricular septal defects
- Ruiz CE, Austin EH III, Cheatham JP, Danford DA, Latson LA, Mayer J, Mullins CE, Sanders S. First Food and Drug Administration approval under Humanitarian Device Exemption of a septal occluder for fenestrated fontan and muscular ventricular septal defects. Circulation. 2000:101:e9042.
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- Ruiz, C.E.¹ Austin III, E.H.² Cheatham, J.P.³ Danford, D.A.⁴ Latson, L.A.⁵ Mayer, J.⁶ Mullins, C.E.⁷ Sanders, S.⁸

11
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- www.closurei.com. Accessed January 3, 2005.

12
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- www.amplatzer.com/us/medical_professionals/respect_trial.html. Accessed January 3, 2005.

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.