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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/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.
Generic Namepulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 coral sea street ne
mounds view, MN 55112
PMA NumberP970012
Date Received02/07/1997
Decision Date01/30/1998
Product Code NVZ 
Docket Number 98M-0231
Notice Date 04/16/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Medtronic.Kappa 400 Series Pacemakers, which includes; Medtronic.Kappa KDR 401/403 & KSR 401/403 Implantable Pulse Generators w/Medtronic.Vision (Model 9952E) Software, & Medtronic Model 9462 Remote Assistant. These devices are indicated for the following: 1)Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent w/increases in activity and/or minute ventilation; 2)Accepted patient conditions warranting chronic cardiac pacing which include: a)symptomatic parosysmal or permanent 2nd or 3rd degree AV block; b) symptomatic bilateral bundle branch block; c) symptomatic parosysmal or transient sinus node dysfunctions w/ or without associated AV conduction disorders; d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) vasovagal syndromes or hypersensitive carotid sinus syndromes. 3) Medtronic.Kappa 400 Series Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifcally indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include: a) various degress of AV block to maintain the atrial contribution to cardiac output; and b) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.
Supplements:  S001 S002 S003 S004 S006 S008 S009 S010 S011 S012 S013 
S014 S015 S016 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 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 
S088 S089 S090 S091 S093 S094 S095 S096 S097 S098 S099 S100