PMA P860004S460
- Device
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S460
- Product code
- LKK
- Decision date
- 2026-08-13
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- implement three additional laser welders
Current openFDA PMA Record#
- Device
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S460
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2026-08-13
- Decision code
- OK30
- Date received
- 2026-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implement three additional laser welders