- Device
- SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (Drug Delivery Infusion Pump 8667)
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S457
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2026-02-06
- Decision code
- OK30
- Date received
- 2026-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement process changes in the manufacture of the 90nm Integrated Circuit (IC) wafer components on behalf of an external supplier