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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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Decision
Date
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surgicel family of hemostats ETHICON, INC. N12159S033 09/24/2014
artegraft collagen vascular graft LeMaitre Vascular, Inc. N16837S015 07/14/2014
disinfecting unit iii Bausch & Lomb, Inc. N16895S015 12/04/1981
advantio, ingenio, vitalio, formio essentio, accolade, proponent, and altrua 2 supported by latitude consult only) (pace Boston Scientific Corp. N970003S184 02/05/2016
titan inflatable penile prosthesis COLOPLAST CORP. P000006S038 11/04/2014
edwards prima plus stentless porcine bioprosthesis EDWARDS LIFESCIENCES, LLC. P000007S039 03/12/2013
lap-band adjustable gastric banding (lagb) system ReShape Lifesciences, Inc. P000008S021 12/14/2010
lap-band adjustable gastric banding system ReShape Lifesciences, Inc. P000008S031 09/24/2014
lap-band adjustable gastric banding system ReShape Lifesciences, Inc. P000008S032 11/05/2014
belos dr-t,belos a+-t,lexos dr-t/lexos vr-t,xelos dr-t,lumos dr-t/lumos vr-t BIOTRONIK, INC. P000009S054 05/08/2013

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