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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 MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030035
Supplement NumberS003
Date Received09/30/2004
Decision Date04/29/2005
Product Code NKE 
Docket Number 05M-0289
Notice Date 07/26/2005
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FRONTIER CARDIAC RESYNCHRONIZATION THERAPY SYSTEM. THESE DEVICES ARE INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. 2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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