GLPs and GMPs: When Are They Necessary? - NAMSA
SUMMARY OF SAFETY AND EFFECTIVENESS DATA . 1. General Information . Device Generic Name: Endovascular Graft . ... P040043/SO40: FDA Summary of Safety and Effectiveness Data Page 1 . 5 . of dissections, includes the treatment of all types of isolated lesions ... new preclinical studies. These data were reviewed under S39 and found adequate to ................
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