PMA P860004S456

Device: Drug Delivery Infusion Pump Model 8667
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S456
Product code: LKK
Decision date: 2026-02-12
Classification: General Hospital
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for die-level traceability implementation and substrate e-Mark process improvement at a sub-tier supplier for Stack Chip Scale Package (SCSP) components.

Current openFDA PMA Record#

Device: Drug Delivery Infusion Pump Model 8667
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S456
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2026-02-12
Decision code: OK30
Date received: 2026-01-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for die-level traceability implementation and substrate e-Mark process improvement at a sub-tier supplier for Stack Chip Scale Package (SCSP) components.