PMA P860004S436

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S436
Product code: LKK
Decision date: 2024-12-18
Classification: General Hospital
Generic name: Pump, infusion, implanted, programmable
Approval order statement: approval for a modification to the manufacturing process regarding the security level changer, including implementation of a work instruction and an update to internal applications to support the security level change process

Current openFDA PMA Record#

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S436
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2024-12-18
Decision code: OK30
Date received: 2024-11-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a modification to the manufacturing process regarding the security level changer, including implementation of a work instruction and an update to internal applications to support the security level change process