PMA P860004S451
- Device
- SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S451
- Product code
- LKK
- Decision date
- 2025-11-13
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- approval for new materials for components used in the Model 8880T2 Clinician Telemetry Module
Current openFDA PMA Record#
- Device
- SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S451
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-11-13
- Decision code
- APPR
- Date received
- 2025-09-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for new materials for components used in the Model 8880T2 Clinician Telemetry Module