- Device
- SynchroMed Infusion System and Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S338
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-08-21
- Decision code
- APPR
- Date received
- 2019-08-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to change the molding process for the SynchroMed Infusion System and Ascenda Intrathecal Catheters components(Fill Port Septum and the Catheter Access Port Septum).