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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS014
Date Received10/24/2001
Decision Date12/14/2001
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic kappa 900/800 pacemaker series models k(dr)901, k(dr)903, k(dr)906, k(dr)921, k(dr)931, k(dr)933, k(dr)801, k(dr)803, k(dr)806, k(d)901, k(d)903, k(d)906, kvdd901, ksr901, ksr903, and ksr906 and model 9988 software series 1. 1. The devices are indicated for the following: 1) rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. 2) accepted patient conditions warranting chronic cardiac pacing which include: a) symptomatic paroxysmal or permanent second or third-degree av block; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunctions with 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 900/800 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: a) various degrees 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. 4) medtronic kappa 900/800 series pacemakers are also indicated for vdd pacing in patients having adequate atrial rates and the following indications: a) 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. B) normal sinus rhythm and normal av conduction in patients needing ventricular pacing intermittently.