PMA P860004S368

Device: SynchroMed Infusion System and Ascenda Intrathecal Catheters
Applicant: Medtronic, Inc.
Product code: LKK
Decision date: 2021-08-30
Generic name: Pump, infusion, implanted, programmable
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.

Current openFDA PMA Record#

Device: SynchroMed Infusion System and Ascenda Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S368
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2021-08-30
Decision code: APPR
Date received: 2021-01-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.