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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: FINELINE II EZ Sterox; FINELINE II Sterox; J Shaped Lead Stylet; Straight Lead Stylet; Suture Sleeves
Classification Name: PERMANENT DEFIBRILLATOR ELECTRODES
Product Code: NVY
Device Class: 3
Registered Establishment Name: Boston Scientific Corporation
Registered Establishment Number: 2124215
Premarket Submission Number: P960004
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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