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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, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP000009
Supplement NumberS015
Date Received03/18/2005
Decision Date06/22/2005
Product Code
MRM[ Registered Establishments with MRM ]
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 IMPLANT CONTROL SYSTEM (ICS) 3000 PROGRAMMING SYSTEM, USING SOFTWARE VERSION 501.U FOR USE WITH THE BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS.
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