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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 NameACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator; pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS007
Date Received01/20/1999
Decision Date08/04/1999
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 a vddr single pass lead system. The device is indicated for the following: the actros slr+ and kairos sl pacemakers are intended to provide vdd or vddr pacing for patients with a healthy sinus node and av conduction abnormalities. These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This include the presence of complete a-v block when: 1) atrial contribution is needed for hemodynamic benefit; and 2) pacemaker syndrome had existed or is anticipated. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration or 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. Additional indications include: normal sinus rhythm and normal a-v conduction in patients who intermittently need ventricular pacing support.
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