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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.
 
Trade NamePROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Nameexternal dual-chamber pacemaker
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS028
Date Received11/15/2002
Decision Date12/06/2002
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) the combination of all the features of the philos family with the closed loop stimulation (cls method of rate adaptive pacing; and 2) the addition of the protos application to the swm and ata programmer software cartridges, the device, as modified, will be marketed under the trade name protos vr and protos dr; and software cartridges b-k00. P. U and a-k00. 0. U, and is indicated for: a) rate adaptive pacing with the protos pacing system is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. B) generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i. E. Bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (sa) block, second- and third-degree av block, and carotid sinus syndrome. C) 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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