PMA P860004S433
- Device
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S433
- Product code
- LKK
- Decision date
- 2025-01-06
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- a change of elemental impurities testing specification, test lab location, and testing frequency on a silicone raw material
Current openFDA PMA Record#
- Device
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S433
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-01-06
- Decision code
- APPR
- Date received
- 2024-10-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a change of elemental impurities testing specification, test lab location, and testing frequency on a silicone raw material