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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.
 
DeviceADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980035
Supplement NumberS374
Date Received04/23/2014
Decision Date03/19/2015
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR IN COMBINATION WITH THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI TO BE MARKETED AS THE ADVISA SR MRI SURESCAN. IN ADDITION YOU REQUESTED APPROVAL FOR MODIFICATIONS TO THE ADVISA SR MRI AND ADVISA DR MRI SOFTWARE APPLICATION MODEL 9995.
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