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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 NameKRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS053
Date Received03/01/2012
Decision Date10/03/2012
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the evia hf/hf-t family of crt-ps and new programmer software identified as 1203. U/1.
Approval Order Approval Order
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