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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 NameMEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE
Classification Namepulse generator, permanent, implantable
Applicant MEDTRONIC INC.
PMA NumberP980035
Date Received08/25/1998
Decision Date01/29/1999
Product Code
NVZ[ Registered Establishments with NVZ ]
Docket Number 99M-2671
Notice Date 08/17/1999
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 medtronic. Kappa(tm) 700/600 series pacemakers, which include; medtronic. Kappa(tm) kdr 701, 703, 706, 721, 731, 733, 601, 603, and 606; kd 701, 703, and 706; kvdd 701; and ksr 701, 703, and 706 implantable pacemakers with medtronic. Vision (model 9953e) software. These devices are indicated for the following: rate adaptive pacing in patients who may benefit from increase pacing rates concurrent with increases in activity; accepted patient conditions warranting chronic cardiac pacing which include: - symptomatic parosysmal or permanents second or third-degree av block; - symptomatic bilateral bundle branch block; - symptomatic paroxysmal or transient sinus node dysfunctions with or without assocated av conduction disorders; - bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; - vasovagal syndromes or hypersensitive carotid sinus syndromes. In addition, medtronic. Kappa(tm) 700/600 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 specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony, which include: -various degrees of av block to maintain the atrial contribution to cardiac output; -vvi intolerance (e. G. , pacemaker syndrome) in the presence of persistent sinus rhythm. Medtronic. Kappa(tm) 700/600 series pacemakers are also indicated for vdd modes in patients having adequate atrial rates and the following indications: - requirements for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete av block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome has existed or is anticipated. Normal sinus rhythm and normal av conduction in patients needing ventricular pacing intermittently.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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