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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameANTHEM AND FRONTIER II CRT-P'S
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP030035
Date Received08/29/2003
Decision Date05/13/2004
Product Code
NKE[ Registered Establishments with NKE ]
Docket Number 04M-0250
Notice Date 05/26/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the st. Jude frontier biventricular cardiac pacing system. The frontier biventricular pacing system is indicated for 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.
Approval Order Approval Order
Supplements: S001 S002 S003 S006 S007 S008 S009 S010 S011 
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S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 
S059 S061 S062 S063 S064 S065 S066 S067 S068 
S069 S070 S071 S072 S073 S074 S075 S076 S077 
S078 S079 S081 S082 S083 S084 S085 S086 S087 
S088 S089 S090 S091 S093 S094 S095 S096 S097 
S098 S099 S100 S101 S102 S103 S104 S105 S107 
S108 S109 S110 S111 S112 S113 S114 S115 S116 
S117 S118 S119 S120 S121 S122 S123 S124 
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