PMA P860004S453
- Device
- SynchroMed™ Infusion Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S453
- Product code
- LKK
- Decision date
- 2025-12-19
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- approval for software changes to the Model A810 SynchroMed Clinician Programmer Application
Current openFDA PMA Record#
- Device
- SynchroMed™ Infusion Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S453
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-12-19
- Decision code
- APPR
- Date received
- 2025-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for software changes to the Model A810 SynchroMed Clinician Programmer Application