Medical device development - From prototype to regulatory approval

被引：102

作者：

Kaplan, AV

Baim, DS

Smith, JJ

Feigal, DA

Simons, M

Jefferys, D

Fogarty, TJ

Kuntz, RE

Leon, MB

机构：

[1] Dartmouth Hitchcock Med Ctr, Cardiol Sect, Dartmouth Med Sch, Lebanon, NH 03756 USA

[2] Brigham & Womens Hosp, Dept Med, Boston, MA 02115 USA

[3] Massachusetts Gen Hosp, Dept Radiol, Boston, MA 02114 USA

[4] Stanford Univ, Dept Surg, Stanford, CA 94305 USA

[5] Lenox Hill Heart & Vasc Inst, New York, NY USA

[6] US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA

来源：

CIRCULATION | 2004年 / 109卷 / 25期

关键词：

D O I：

10.1161/01.CIR.0000134695.65733.64

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

[No abstract available]

引用

页码：3068 / 3072

页数：5

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[2]

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Feigal, DW ;

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[4] Retrieval and analysis of particulate debris after saphenous vein graft intervention [J].

Webb, JG ;

Carere, RG ;

Virmani, R ;

Baim, D ;

Teirstein, PS ;

Whitlow, P ;

McQueen, C ;

Kolodgie, FD ;

Buller, E ;

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Mancini, GBJ ;

Oesterle, S .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 1999, 34 (02) :468-475

[5]

1996, FED REG, V61, P33233

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