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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 18 Results
productcode MIH PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
 
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PMA
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TREO® Abdominal Stent-Graft System Bolton Medical Inc. P190015 S018 05/03/2024
Zenith Fenestrated AAA Endovascular Graft COOK, INC. P020018 S063 04/29/2024
Zenith Alpha Thoracic Endovascular Graft COOK MEDICAL INCORPORATED P140016 S011 04/29/2024
Zenith Dissection Endovascular System WILLIAM COOK EUROPE APS P180001 S012 04/29/2024
RelayPlus Thoracic Stent-Graft System BOLTON MEDICAL, INC. P110038 S031 04/17/2024
TREO Abdominal Stent-Graft System Bolton Medical Inc. P190015 S017 04/17/2024
RelayPro Stent-Graft System Bolton Medical, Inc. P200045 S011 04/17/2024
Medtronic CoreValve™ Evolut PRO System, Endurant I... Medtronic Vascular P100021 S120 04/10/2024
Valiant Thoracic Stent Graft with the Captivia Del... Medtronic Vascular P100040 S062 04/10/2024
GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (C... W. L. Gore and Associates, Inc P200030 S014 04/05/2024
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