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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 FAMILY OF CRT-PS
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantST. JUDE MEDICAL
PMA NumberP030035
Supplement NumberS048
Date Received10/14/2008
Decision Date11/13/2008
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate vendor for the parylene dimer used to parylene coat pacemakers and crt-ps.
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