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# FDA Approves Medtronic PMA Supplement for IN.PACT Admiral
- URL: https://www.fdaweb.com/fda-approves-medtronic-pma-supplement-for-in-pact-admiral/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136168

FDA has approved a Medtronic PMA supplement for the IN.PACT Admiral drug-coated balloon (DCB) in longer (150 mm lengths), which will be available in four, five, and six mm diameters, for treating long lesions in patients with peripheral artery disease. “The long lesion (10-18 cm) sub-group outcomes from the IN.PACT SFA Trial at one year demonstrated superiority over balloon angioplasty,” the company says. “There were no device or procedure-related deaths, no occurrences of major target limb amputation, and a 3.9% thrombosis rate in the IN.PACT Admiral DCB arm versus 5.9% in the \[percutaneous transluminal angioplasty\] PTA arm through 12 months (p=0.326) in this subgroup.”