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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 Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator,pacemaker programmer;icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS004
Date Received04/27/2001
Decision Date07/12/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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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