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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.
 
DeviceASTRA S DR MRI IPG X3DR01, ASTRA S SR MRI IPG X3SR01, ASTRA XT DR MRI IPG X1DR01, ASTRA XT SR MRI IPG X1SR01
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980035
Supplement NumberS509
Date Received06/08/2017
Decision Date06/28/2017
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Update to the Distribution Center Sorter Tool.
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