PMA P860004S452

Device: SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S452
Product code: LKK
Decision date: 2025-10-16
Classification: General Hospital
Generic name: Pump, infusion, implanted, programmable
Approval order statement: for update to Energy and Components Center (MECC), specifically to update the Programmable Logic Controller (PLC) software to correct an AddUser function on the Medium Rate (MR) Cell Operating Fill Station (COS).

Current openFDA PMA Record#

Device: SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S452
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2025-10-16
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for update to Energy and Components Center (MECC), specifically to update the Programmable Logic Controller (PLC) software to correct an AddUser function on the Medium Rate (MR) Cell Operating Fill Station (COS).