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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 VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Classification Nametester, pacemaker electrode function
Generic Nametester, pacemaker electrode function
Regulation Number870.3720
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS004
Date Received04/27/2001
Decision Date07/12/2001
Product Code
DTA[ Registered Establishments with DTA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for a new icd system that includes the following: belos vr icd (model 330 444), belos test housing (model 331 116), and belos vr phylax xm/mycrophylax/phylax 06/tms 1000 application software 1-k01. 0. A (model 338 045). The device, as modified is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.
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