Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 2 de 2
Filter
Add more filters










Database
Language
Publication year range
2.
Fed Regist ; 69(120): 34917-20, 2004 Jun 23.
Article in English | MEDLINE | ID: mdl-15224687

ABSTRACT

The Food and Drug Administration (FDA) is requiring the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.


Subject(s)
Blood Gas Analysis/instrumentation , Cardiopulmonary Bypass/instrumentation , Device Approval/legislation & jurisprudence , Plethysmography/instrumentation , Cardiopulmonary Bypass/legislation & jurisprudence , Humans , United States , United States Food and Drug Administration
SELECTION OF CITATIONS
SEARCH DETAIL
...