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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, pacemaker programmer
Regulation Number870.3610
PMA NumberP950037
Supplement NumberS001
Date Received03/31/1997
Decision Date03/13/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a capacitive sensor, integrated circuit change and its supporting circuityr, hybrid circuit modification, battery change, pacemaker housing change, modified header, pms 1000 c programmer, and the swm 1000 f01. B00. U software. The device, as modified, will be marketed under the trade name actros pacing system which consists of the following:actros dr, d, sr, and s models, pms 1000 c programmers, swm 1000 (version f01. B00. U). Rate adaptive pacing with the actros dr and actros sr pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrom (i. E. , bradycardiatachcardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (sa) block, second- and third- degree av block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of av synchrony should be considered for one of te dual-chamber or atrial pacing modes. Dual-chamber modes are specfically indicated for treatment of conduction disorders that require both restoration of rate and av synchrony such as av nodal disease, diminished cardiac output or congestive heart failure associated with coduction distrurbances, and tachyarrhythmias that are suppressed by chronic pacing.