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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Bard RF Cardiac Ablation Generator Footswitch; Bard RF Cardiac Ablation Generator to Biotronik Ablation Catheter Adaptor Cable; Bard RF Cardiac Ablation Generator to Blazer Ablation Catheter Adaptor Cable; Bard RF Cardiac Ablation Generator to Celsius Ablation Catheter Adaptor Cable; Bard RF Cardiac Ablation Generator to Conductr Ablation Catheter Adaptor Cable; Bard RF Cardiac Ablation Generator to Dual Patient Pad Reference Cable; Bard RF Cardiac Ablation Generator to TempLink / TempLink M Cable; Bard RF Cardiac Ablation Generator to Thermocool Ablation Catheter Adaptor Cable; Chilli II Cooled Ablation Catheter; HD Mesh Ablator Catheter to EnSite NavX Imaging System Cable Adaptor; HD Mesh Ablator Diagnostic and Ablation Catheter; HD Mesh Ablator Extension Cable Kit; HD Mesh Mapper Catheter; HD Mesh Mapper Extension Cable Kit; Scorpion 2 Ablation Catheter; Scorpion 2 M Ablation Catheter; Stinger Ablation Catheter; Stinger M Ablation Catheter; Stinger S Ablation Catheter; Stinger SM Ablation Catheter; Tempulse Pulsed RF Controller CLEARSIGN Amplifier IECG Cable; Tempulse Pulsed RF Controller Dual Patient Reference Cable; Tempulse Pulsed RF Controller RF Generator Power Cable; Tempulse Pulsed RF Controller RF Generator Reference Cable; Tempulse Pulsed RF Controller STAMP Amplifier IECG Cable; Tempulse Pulsed RF Controller Universal IECG Cable
Classification Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
Product Code: LPB
Device Class: 3
Registered Establishment Name: Boston Scientific Corporation
Registered Establishment Number: 3001236349
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: U.S. Manufacturer of Export Only Devices
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