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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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sientra silicone gel breast implants SIENTRA, INC P070004S008 12/02/2016
sientra silicone gel breast implants SIENTRA, INC P070004S004 06/07/2012
sientra silicone gel breast implants SIENTRA, INC P070004S006 12/18/2013
advia centaur hbc igm readypack reagents, advia centaur hbc igm quality control materials SIEMENS HEALTHCARE DIAGNOSTICS P030040 08/06/2004
advia centaur hbsag (hbs) assay SIEMENS HEALTHCARE DIAGNOSTICS P030049S011 10/28/2014
dermagraft SHIRE REGENERATIVE MEDICINE P000036S011 09/05/2012
scimed ptca dilatation catheter SCIMED LIFE SYSTEMS, INC. P860019S016 02/21/1989
apex ptca & nc quantum apex ptca catheters SCIMED LIFE SYSTEMS, INC. P860019S263 09/08/2010
scimed percutaneous transluminal coronary angioplasty catheters and trapper exchange device SCIMED LIFE SYSTEMS, INC. P860019S102 11/20/1995
synvisc, synvisc-one Sanofi GENZYME CORP. P940015S033 08/21/2014

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