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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CapSureFix MRI SureScan Lead; Revo MRI SureScan
Classification Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Product Code: LWP
Device Class: 3
Registered Establishment Name: Medtronic Europe Sarl
Registered Establishment Number: 9614453
Premarket Submission Number: P090013
Owner/Operator: Medtronic, Inc.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer
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