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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 LPB PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
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BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLA... Boston Scientific Corp. P920047 S131 04/05/2024
7F Freezor Cardiac Cryoablation Catheter, 7F Freez... Medtronic CryoCath LP P020045 S109 03/29/2024
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S059 02/19/2024
SmartAblate™ Irrigation Tubing Set (SAT001) BIOSENSE WEBSTER, INC. P990071 S058 02/16/2024
Nitron CryoConsole and Nitron Remote Medtronic CryoCath LP P020045 S105 02/01/2024
7F Freezor Cardiac Cryoablation Catheter, 7F Freez... Medtronic CryoCath LP P020045 S108 01/08/2024
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