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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™ Infusion System, Ascenda™ Intrathecal Catheters
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS465
Date Received09/30/2026
Decision Date10/30/2026
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the following three changes: 1) Adding a new surface mount technology (SMT) production line.2) Revision of the SMT manufacturing process sequence to perform automated optical inspection immediately following each SMT assembly stage.3) Addition of an equivalent solder paste inspection system and addition of a qualified de-paneling machine for PCBA production
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