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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 HV SPLITTER/ADAPTOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
ApplicantMEDTRONIC, INC.
PMA NumberP920015
Supplement NumberS106
Date Received03/21/2013
Decision Date04/12/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations; 2) an additional supplier for extruded tubing; transfer of incoming inspection location for various components; 3) modifications to a controlled environment; and 4)an alternate supplier of a silicone component.
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