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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 4-Site Lead Pulling Tip, 4-SITE; 4-SITE Terminal Tool; ACUITY X4 Connector Tool; Bipolar Positive Fixation lead & adapter; ENDOTAK C; ENDOTAK DSP; ENDOTAK ENDURANCE; ENDOTAK ENDURANCE EZ; ENDOTAK ENDURANCE Rx; ENDOTAK RELIANCE; ENDOTAK RELIANCE 4-Site Active; ENDOTAK RELIANCE 4-Site Passive; ENDOTAK RELIANCE G 4-Site Active; ENDOTAK RELIANCE G 4-Site Passive; ENDOTAK RELIANCE G, Active; ENDOTAK RELIANCE G, Passive; ENDOTAK RELIANCE S; ENDOTAK RELIANCE S 4-Site Active; ENDOTAK RELIANCE S 4-Site Passive; ENDOTAK RELIANCE SG 4-Site Active; ENDOTAK RELIANCE SG 4-Site Passive; ENDOTAK RELIANCE SG, Active; ENDOTAK RELIANCE SG, Passive; ENDOTAK SQ Array; ENDOTAK SQ Array XP; ENDOTAK SQ Patch Lead; Lead Adapter; Lead Cap Accessory Kit; Lead Cap Kit; Lead Stabilizer Kit; Lead Tunneler Kit; Lead Tunneling Tip; Stylet
Product Code: LWS
Device Class: 3
Registered Establishment Name: Boston Scientific Corporation
Registered Establishment Number: 2648729
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer