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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.
 
DeviceADAPTA/VERSA/SENSIA/RELIA IPG IMPLANTABLE PULSE GENERATOR
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS147
Date Received11/17/2009
Decision Date03/22/2011
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 NEW APPLICATION SOFTWARE VERSION SW003 (VERSION 7.1); RELIA APPLICATION SOFTWARE VERSION SW010 (VERSION 7.1); AND CARELINK DDMA VERSION K3 DDMA1 2V4.
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