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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 NumberS308
Date Received05/07/2018
Decision Date06/01/2018
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  
Update of the software used to apply, collect, and record data from the Helium Leak Test on batteries and capacitors, and a change in the platform used to execute FACTORYworks transactions for the leak test systems.
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