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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Accent; Sustain XL SC, DC, SR, DR;; Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable,; Merlin Patient Care System Software Model 3330 Version 18.1.1; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR
Classification Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
Product Code: DXY
Device Class: 3
Regulation Number: 870.3610
Medical Specialty: Cardiovascular
Registered Establishment Name: ABBOTT MEDICAL
Registered Establishment Number: 2017865
Premarket Submission Number: P880086
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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