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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 (ICS 3000 802.U/2)
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS036
Date Received11/19/2008
Decision Date03/31/2009
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Clinical Trials NCT00508391
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) commercial distribution of the lumax hf-t crt-ds and stratos lv (-t) crt-ps with ventricle to ventricle (v-v) delay features; and 2) updated model ics 3000 programmer software (release of 802. U/2) to implement the v-v delay features and other minor enhancements.
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