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Modifications to devices subject to premarket approval (PMA) the PMA supplement decision-making proc

[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] 2008

Modifications to devices subject to premarket approval (PMA) the PMA supplement decision-making proc

[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] 2008