- Device
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S382
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-12-03
- Decision code
- OK30
- Date received
- 2021-11-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of current Underfill Dispense System (Asymtek Axiom X-1020) with a new system (Asymtek Spectrum II) at Medtronic Tempe Campus (MTC).