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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants Allergan P040046S012 08/03/2015
novaflex delivery system EDWARDS LIFESCIENCES, LLC. P130009S016 07/21/2015
livewire tc ablation catheter, safire ablation catheter St. Jude Medical P960016S050 07/09/2015
safire duo and cool path duo ablation catheters Abbott Medical P110016S014 07/09/2015
therapy dual ablation catheter, safire tx ablation catheter IRVINE BIOMEDICAL,INC.(IBI) P040042S029 07/09/2015
in.pact admiral dcb MEDTRONIC Inc. P140010S005 07/09/2015
promus element plus everolimus - eluting platinum chromium coronary stent system Boston Scientific Corp. P110010S099 07/07/2015
essure system for permanent birth control BAYER PHARMA AG P020014S041 06/29/2015
animas vibe system ANIMAS CORP. P130007S002 06/22/2015
esteem ENVOY MEDICAL CORPORATION P090018S029 06/19/2015

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