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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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PMA
Number
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Decision
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lifevest wearable defibrillator ZOLL MANUFACTURING CORPORATION P010030S049 05/19/2014
gore excluder aaa endoprosthesis W.L. GORE & ASSOCIATES,INC P020004S092 06/20/2014
gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface W.L. GORE & ASSOCIATES,INC P040037S060 09/19/2014
gore viabahn endoprosthesis W.L. GORE & ASSOCIATES,INC P040037S074 01/08/2015
gore viabahn endoprosthesis with heparin bioactive surface W.L. GORE & ASSOCIATES,INC P130006S014 01/08/2015
gore viabahn vbx balloon expandable endoprosthesis W. L. Gore & Associates, Inc. P160021S026 04/08/2020
vistakon (senofilcon a) contact lens, clear and visibility tinted with uv blocker VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR P040045 12/20/2005
vistakon (senofilcon a) brand contact lenses VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR P040045S030 12/15/2011
pathway anti-hcr-2/ncu (4b5) rabbit monoclonal primary antibody VENTANA MEDICAL SYSTEMS, INC. P990081 11/28/2000
inform her2 dual ish dna probe cocktail VENTANA MEDICAL SYSTEMS, INC. P100027S019 02/19/2015

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