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10.3168/jds.s0022-0302(90)78707-3 461 PazA.Zeev-Ben-MordehaiT.LundqvistM.ShermanE.MylonasE.WeinerL.et al (2008)

We also note that the device associated with this procedure (AGENT TM Paclitaxel-Coated Balloon Catheter) received device pass-through status effective January 1, 2025 (89 FR 91434 through 91439)