PMA P860004S450

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S450
Product code: LKK
Decision date: 2025-09-18
Classification: General Hospital
Generic name: Pump, infusion, implanted, programmable
Approval order statement: approval for updates to the medium rate battery manufacturing process

Current openFDA PMA Record#

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S450
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2025-09-18
Decision code: OK30
Date received: 2025-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for updates to the medium rate battery manufacturing process