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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 NamePROGRAMMER SOFTWARE A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATS
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS013
Date Received08/27/2004
Decision Date09/17/2004
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the programmer software a-k00. 2. U in the lexos, belos and cardiac airbag implantable cardioverter defibrillators.
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