Premarket Approval (PMA)

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 Name: ST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM
• Classification Name: pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P030035
• Date Received: 08/29/2003
• Decision Date: 05/13/2004
• 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

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 S012 S015 S016 ; S017 S018 S019 S020 S021 S022 ; S023 S024 S025 S026 S027 S028 ; S029 S030 S031 S032 S033 S034 ; S035 S036 S037 S038 S039 S040 ; 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 ; S099 S100 S101 S102 S103 S104 ; S105 S107 S109 S110 S111