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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DevicePromote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Abbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030054
Supplement NumberS344
Date Received01/18/2018
Decision Date04/11/2018
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for cybersecurity updates and implementation of a Battery Performance Alert in the firmware of ICDs and CRT-Ds.