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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.
 
DeviceBELOS VR-T ICD
Classification Nametester, pacemaker electrode function
Generic Nametester, pacemaker electrode function
Regulation Number870.3720
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS008
Date Received04/08/2002
Decision Date04/24/2002
Product Code
DTA[ Registered Establishments with DTA ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE BELOS VR-T ICD HOME MONITORING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS VR-T ICD WITH PROGRAMMER SOFTWARE (I-K01.0.A/5) AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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