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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
Number
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Date
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revo mri, surescan ipg Medtronic, Inc P090013S206 12/08/2015
epic vascular self-expanding stent system Boston Scientific Corp. P110035S032 11/30/2015
aptima hpv assay GEN-PROBE INCORPORATED P100042S007 11/24/2015
lutonix drug coated balloon LUTONIX P130024S003 11/23/2015
lutonix 035 drug coated balloon pta catheter LUTONIX P130024S005 11/20/2015
envista hydrophobic intraocular lens Bausch & Lomb, Inc. P910056S019 11/19/2015
cobas egfr mutation test v2 ROCHE P120019S007 11/13/2015
progensa pca3 assay GEN-PROBE INCORPORATED P100033S004 11/12/2015
enlite sensor MEDTRONIC Inc. P120010S029 11/12/2015
sof-sensor MEDTRONIC MINIMED P980022S159 11/12/2015

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