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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 NameMODEL 5019 HIGH VOLTAGE (HV) SPLITTER/ADAPTOR KIT
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS093
Date Received07/02/2012
Decision Date02/13/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 5019 high voltage splitter/ adaptor kit.
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