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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Attain; Attain Bipolar OTW Lead; Attain OTW; CareLink SmartSync Percepta, Solera, Serena Application; Consulta CRT-P; Insync; Percepta CRT-P MRI SureScan; Percepta Quad CRT-P MRI SureScan; Serena CRT-P MRI SureScan; Serena Quad CRT-P MRI SureScan; Solara CRT-P MRI SureScan; Solara Quad CRT-P MRI SureScan; Syncra CRT-P; Viva CRT-P
Classification Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
Product Code: NVZ
Device Class: 3
Registered Establishment Name: Medtronic Europe Sarl
Registered Establishment Number: 9614453
Premarket Submission Number: P010015
Owner/Operator: Medtronic, Inc.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer; Repackager/Relabeler
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