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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.
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator
PMA NumberP970012
Date Received02/07/1997
Decision Date01/30/1998
Product Code
NVZ[ Registered Establishments with NVZ ]
Docket Number 98M-0231
Notice Date 04/16/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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.
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