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Title Modifications to devices subject to premarket approval (PMA) [electronic resource] : the PMA supplement decision-making process.

Imprint [Silver Spring, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; [Rockville, Md.] : Center for Biologics Evaluation and Research, [2008]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:D 49    ---  Available
Description 25 p. : digital, PDF file
System Details Mode of access via the FDA web site.
Note Title from PDF title page (viewed on Mar. 24, 2009).
"December 11, 2008."
Subject Medical instruments and apparatus -- Testing.
Added Author Center for Devices and Radiological Health (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Note At head of title: Guidance for industry and FDA staff
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:D 49

 
    
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