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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.
 
DeviceCurrent, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+ familyof ICD's
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS396
Date Received10/30/2017
Decision Date11/09/2017
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for a software update to the Merlin PCS Programmer software version 24.0.1 Rev. 1 and a pacemaker firmware update.
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