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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 BIVENTRICULAR CARDIAC PACING SYSTEM
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP030035
Supplement NumberS002
Date Received08/13/2004
Decision Date01/14/2005
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study for your device.
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