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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMODEL 5019 HV SPLITTER/ADAPTOR
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP920015
Supplement NumberS106
Date Received03/21/2013
Decision Date04/12/2013
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNALSUPPLIERS 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; AND4)AN ALTERNATE SUPPLIER OF A SILICONE COMPONENT.
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