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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantST. JUDE MEDICAL
PMA NumberP030035
Supplement NumberS078
Date Received03/09/2011
Decision Date08/02/2011
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional manufacturing screening tests for a device component.
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