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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 46 Results
productcode LPB PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PMA
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Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corp. P920047 S106 12/01/2017
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corp. P980003 S083 12/01/2017
Freezor Cardiac CryoAblation System Medtronic CryoCath LP P020045 S084 11/27/2017
Blazer II Cardiac Ablation System Boston Scientific Corp. P920047 S105 11/01/2017
Chilli II Cooled RF Ablation System Boston Scientific Corp. P980003 S082 11/01/2017
Navistar Thermocool Deflectable Diagnostics/Ablati... BIOSENSE WEBSTER, INC. P040036 S058 10/24/2017
Webster Diag/ Ablation Deflectable Tip Catheter Biosense Webster, Inc P950005 S064 10/24/2017
Safire Bi-Directional Ablation Catheters, Livewire... St. Jude Medical P960016 S070 10/24/2017
Navistar Thermo Cool Deflectable Diagnostic/Ablati... BIOSENSE WEBSTER, INC. P040036 S061 10/17/2017
Webster Diag./Ablation Deflectable Tip Catheter Biosense Webster, Inc P950005 S068 10/17/2017
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