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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.
 
DeviceAPPLICATION SOFTWARE, MEDTRONIC GEM ICD, MEDTRONIC JEWEL ICD, MEDTRONIC JEWEL PLUS ICD, MEDTRONIC MICRO JEWEL ICD,MEDTRO
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP900061
Supplement NumberS134
Date Received04/14/2015
Decision Date06/04/2015
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
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