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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.
 
DeviceFRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP030035
Supplement NumberS138
Date Received08/17/2015
Decision Date02/12/2016
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
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