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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.
 
DeviceSynchroMed™ III Pump
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave. NE
Minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS404
Date Received12/05/2022
Decision Date10/06/2023
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval of the SynchroMed III Pump, which includes updated firmware/software, manufacturing processes, labeling, and distribution temperature range.
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