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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.
 
DeviceALL RATE RESPONSIVE IMPLANTABLE PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP950029
Supplement NumberS031
Date Received08/29/2007
Decision Date11/13/2007
Product Code NVZ 
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 THE SMARTVIEW 2.02 UG2 SOFTWARE AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS (MANAGER, OVATION) AND TO INCLUDE A DOWNLOADABLE RAM PATCH (SYMPHONY/ RHAPSODY).
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