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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 PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP950029
Supplement NumberS032
Date Received11/09/2007
Decision Date07/25/2008
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REPLY SR/DR PACEMAKER MODELS AND SMARTVIEW 2.08UG1 PROGRAMMING SOFTWARE MANUFACTURED BY SORIN BIOMEDICA CRM, S.R.L., SALUGGIA (VC) ITALY.
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