JOR

Generator, Pulsatile Flow, Cardiopulmonary Bypass

产品代码

JOR

器械名称

Generator, Pulsatile Flow, Cardiopulmonary Bypass

管理类别

第 3 类（Class III）

21 CFR 条款

21 CFR 870.4320

FDA 专业组

Cardiovascular

上市路径

需 PMA 上市前批准

FDA 分类定义

Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。