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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 NameBELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS005
Date Received09/25/2002
Decision Date12/20/2002
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) new additional pulse generators to the belos family of implantable cardioverter defibrillators, and 2) modifications to the legally marketed belos vr/vr-t icd systems. The device, as modified, will be marketed under the trade name belos dr, dr-t, vr, vr-t icd systems and is indicated for ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life threatening ventricular arrhymias.
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