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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 13 Results
productcode NWX PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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WOLVERINE Coronary Cutting Balloon Boston Scientific Corp. P950020 S142 12/12/2023
FLEXATOME CUTTING BALLOON Boston Scientific Corp. P950020 S141 10/30/2023
AngioSculpt® Evo RX PTCA Scoring Balloon Catheter ... SPECTRANETICS CORP. P050018 S033 10/19/2023
WOLVERINE™ Coronary Cutting Balloon® Boston Scientific Corp. P950020 S140 08/03/2023
WOLVERINE Coronary Cutting Balloon Boston Scientific Corp. P950020 S139 07/27/2023
AngioSculpt RX PTCA Scoring Balloon Catheter, Angi... SPECTRANETICS CORP. P050018 S032 07/07/2023
Scoreflex NC OrbusNeich Medical (Shenzhen) P200041 S001 06/29/2023
Wolverine Coronary Cutting Balloon Boston Scientific Corp. P950020 S138 05/05/2023
WOLVERINE™ Coronary Cutting Balloon® Boston Scientific Corp. P950020 S137 04/26/2023
WOLVERINE™ Coronary Cutting Balloon® Boston Scientific Corp. P950020 S135 03/10/2023
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