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U.S. Department of Health and Human Services

Premarket Approval - PMA
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inspiris resilia aortic valve EDWARDS LIFESCIENCES, LLC. P150048S015 02/28/2018
acrysof posterior chamber single piece intraocular lenses ALCON LABORATORIES, INC. P930014S108 12/18/2017
attain ability/performa lead MEDTRONIC Inc. P080006S109 06/22/2017
helistat absorbable collagen hemostatic agent and helitene- fibrillar form INTEGRA LIFESCIENCES CORPORATION P850010S075 04/24/2017
proact adjustable continence therapy for men UROMEDICA INC P130018S001 11/02/2016
protege,prodigy,proclaim elite family of scs ipgs and scs epg Abbott Medical P010032S109 10/03/2016
aptima hcv rna qualitative assay GEN-PROBE P020011S009 09/19/2016
precision spectra spinal cord stimulator (scs) system Boston Scientific Corp. P030017S245 07/28/2016
cobas hpv test, 240 tests; cobas hpv test, 960 tests Roche Molecular Systems, Inc. P100020S017 07/07/2016
nucleus abi541 auditory brainstem implant Cochlear Americas P000015S012 06/13/2016

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