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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 6 of 6 Results
productcode NIN PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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Device
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Applicant
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PMA
Number
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Decision
Date
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Express® SD Renal Monorail Premounted Stent System Boston Scientific Corp. P060006 S109 12/12/2023
Express SD Renal Boston Scientific Corp. P060006 S108 08/31/2023
Express® SD Renal Monorail Premounted Stent System Boston Scientific Corp. P060006 S107 07/27/2023
RX Herculink Elite Renal and Biliary Stent System ABBOTT VASCULAR P110001 S020 06/14/2023
Express SD Renal Monorail Premounted Stent System Boston Scientific Corp. P060006 S106 03/08/2023
Express SD Renal Monorail Premounted Stent System Boston Scientific Corp. P060006 S105 03/02/2023
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