PMA P860004S394

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S394
Product code: LKK
Decision date: 2022-07-28
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Change to the Ionograph Out-of-Control Action Plan (OCAP) and the test sampling plan within the Final Clean process for hybrids manufactured at Medtronic Tempe Campus (MTC).

Current openFDA PMA Record#

Device: SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S394
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2022-07-28
Decision code: OK30
Date received: 2022-07-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the Ionograph Out-of-Control Action Plan (OCAP) and the test sampling plan within the Final Clean process for hybrids manufactured at Medtronic Tempe Campus (MTC).