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. |
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Device | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S002 |
Date Received | 07/06/1998 |
Decision Date | 08/13/1998 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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 C programmers, 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 syndrome (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 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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