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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode PRL PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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GORE® VIABAHN® VBX Balloon Expandable Endoprosthes... W. L. Gore & Associates, Inc. P160021 S039 11/15/2023
iCast Covered Stent System ATRIUM MEDICAL CORP. P120003 S003 10/18/2023
iCast Covered Stent System ATRIUM MEDICAL CORP. P120003 S002 09/12/2023
GORE® VIABAHN® VBX Balloon Expandable Endoprosthes... W. L. Gore & Associates, Inc. P160021 S040 07/13/2023
iCast Covered Stent System ATRIUM MEDICAL CORP. P120003 S001 07/12/2023
GORE® VIABAHN® VBX Balloon Expandable Endoprosthes... W. L. Gore & Associates, Inc. P160021 S041 07/05/2023
GORE® VIABAHN® VBX Balloon Expandable Endoprosthes... W. L. Gore & Associates, Inc. P160021 S038 04/24/2023
iCast Covered Stent System ATRIUM MEDICAL CORP. P120003 03/22/2023
GORE® VIABAHN® VBX Balloon Expandable Endoprosthes... W. L. Gore & Associates, Inc. P160021 S037 03/16/2023
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