Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: ACTIVITRAX MODELS 8400, 8402, 8403
• Generic Name: Pulse-generator, single chamber, sensor driven, implantable
• Applicant: MEDTRONIC Inc.; 8200 Coral Sea Street NE; Mounds View, MN 55112
• PMA Number: P850051
• Date Received: 07/19/1985
• Decision Date: 06/10/1986
• Product Code: LWO
• Docket Number: 86M-0266
• Notice Date: 07/11/1986
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S075 S076 S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 ; S012 S013 S014 S015 S016 S017 S020 S021 S022 S023 S024 S025 ; S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 ; S038 S039 S040 S041 S043 S044 S045 S046 S048 S049 S078 ; S050 S051 S052 S082 S074 S056 S060 S061 S062 S071 S068 S054 ; S066 S057 S055 S077 S079 S080 S084 S081 S083 S067 S064 S072 ; S069 S070 S065 S073