definiens: means a Liccn5C : d Product containing ] eithcr or both ] ( i ) an IElF Decoy described in Seaion 1.37(b ) or ] ( ii ) a Licensed Device lother Ihan ( M tII : II ] for whith ] Initial Regulatory Approval is oblained or ( 8)1 any L.icensed Device for which JApproval can be sought based u ~ n II demonstration Ihat 5Uch Licensed Device is substantially equhllJen tJ to the Licensed Device ] uisllng as of the Effective Date, IS delCrnllned pursuant 10 2:1 CfR Pan 807 or the equivalcn l thereof ] outside the United States, 1.78 means a peripheral artery bypass vafl ., Iypically composed of saphenous veins ( although other ~es : se1s can be used ), that are implanted inlO pa.tienlS wilh an occluded or 51enoscd artery in the periphery 10 byp8ss such o«lusion or stenosis Dnd to provide blood now to otherwise ischemic tiS$llC