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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Cosmos; Cosmos II; Galaxy; Nova; Nova II; Nova III; Quantum II; Quantum III; SuPrima III
Classification Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Product Code: LWP
Device Class: 3
Registered Establishment Name: Boston Scientific Corporation
Registered Establishment Number: 2124215
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Specification Developer
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