- Device
- SynchroMed Infusion System and Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S345
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-05-15
- Decision code
- APPR
- Date received
- 2019-10-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to change to a PFOA-free manufacturing process on a component of the non-implanted Anchor Dispenser Tool using an existing approved sub-tier supplier.