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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.
 
DeviceREPLY (V2) AND ESPRIT DEVICES
Generic NamePulse generator, permanent, implantable
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP950029
Supplement NumberS049
Date Received11/04/2009
Decision Date06/18/2010
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 SOFTWARE VERSIONS W2.7.3 AND W2.7.4 FOR THE REPLY (V2) AND ESPRIT PACEMAKERS.
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