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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Premere PFO Closure System
Classification Name: TRANSCATHETER SEPTAL OCCLUDER
Product Code: MLV
Device Class: 3
Registered Establishment Name: ST. JUDE MEDICAL
Registered Establishment Number: 2182269
Owner/Operator: St. Jude Medical, Inc.
Owner/Operator Number: 2126673
Establishment Operations: U.S. Manufacturer of Export Only Devices
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