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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 AND RELIA IPG FAMILIES
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS140
Date Received07/28/2009
Decision Date09/25/2009
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 DESIGN CHANGES TO THE L368 INTEGRATED CIRCUIT INCLUDING MODIFICATIONS TO THE CHARGE AMP OFFSET CIRCUIT, AUTOPOLARITY SHORT CIRCUIT PACE THRESHOLD CIRCUIT, AND KEITHLEY STRUCTURE AS WELL AS A FAMILY IDENTIFICATION CHANGE IN THE INTEGRATED CIRCUIT FOR THE RELIA.
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