- Device
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S448
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-08-29
- Decision code
- APPR
- Date received
- 2025-07-31
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for updates to the Targeted Drug Delivery (TDD) Therapy labeling for the SynchroMed II in the labeling for SynchroMed infusion system