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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Accessory kit; Antenna Accessory; Bifurcated Bipolar Endocardial Tined Lead; DF-1 Plug; Large Patch Lead; LATITUDE Communicator Inductive; LATITUDE Communicator RF; LATITUDE Consult Communicator; LATITUDE Consult System Software; LATITUDE G2 Communicator; LATITUDE NXT Server Software; LATITUDE Server Software; LATITUDE WAVE Communicator; Multiple Application Utility (MAU); Programmer Recorder Monitor (PRM) System Zoom; Small Patch Lead; Software Disk for the VENTAK MINI Pulse Generators; Software Disk for the VENTAK PRx II / III Pulse Generators; Software Disk for the VENTAK PRx Pulse Generators; USB Cable; VENTAK MINI; VENTAK MINI HE; VENTAK MINI II; VENTAK MINI III; VENTAK MINI III HE; VENTAK MINI IV; VENTAK PRx II; VENTAK PRx III; ZOOM LATITUDE Programmer/Recorder/Monitor; ZOOM Wireless Transmitter
Product Code: OSR
Device Class: 3
Registered Establishment Name: Boston Scientific Limited
Registered Establishment Number: 9616693
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer