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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 and Ascenda Intrathecal Catheters
Generic Namepump, infusion, implanted, programmable
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS368
Date Received01/25/2021
Decision Date08/30/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a cleaning process change at DSM Biomedical in Berkeley California, a supplier to Medtronic Neuromodulation, that involves the addition of an option to replace solvent cleaning the equipment between material lots with a process that uses the next lot of material to purge the system (the first 30 seconds of material coming out of this portion of the manufacturing line is discarded). The change involves the continuous reactor system to be purged between production batches of same hardness grade and purged and cleaned between production batches of different hardness.