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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 NameBIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator;programmer software
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS020
Date Received06/11/2001
Decision Date10/10/2001
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for pulse generator and programmer software. The device, as modified, will be marketed under the trade name inos2+ and is indicated for the following applications: 1) rate adaptive pacing with the inos pacing system is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. 2) 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. 3) patients whom 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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