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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 II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP030035
Supplement NumberS001
Date Received07/21/2004
Decision Date08/16/2004
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the frontier ii model 5586 biventricular pulse generator with the model 3307, v4. 8m programmer software.
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