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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS003
Date Received06/09/1998
Decision Date08/13/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Scan Hysteresis feature, Repetitive Hysteresis feature, and Night Mode feature associated with the PMS 1000 C programmer, and the SWM 1000 F03.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 Cprogrammer, SWM 1000 (Version F03.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 increased 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 syndrom, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically 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 conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
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