- Device
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S454
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-11-26
- Decision code
- APPR
- Date received
- 2025-10-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing site change to add Medtronic Puerto Rico Operations Company, Villalba facility (MVC) as an alternate sterilization site for Neuromodulation/Pelvic Health (NMPH) Implantable Neurostimulators (INS), Drug Delivery Infusion Pumps (SynchroMed), Catheters and Accessories