PMA P860004S400
- Device
- SynchroMed® Infusion System
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S400
- Product code
- LKK
- Decision date
- 2022-10-26
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Implementation of a duplicate cleaning line and an update from manual operation to automatic operation.
Current openFDA PMA Record#
- Device
- SynchroMed® Infusion System
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S400
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2022-10-26
- Decision code
- OK30
- Date received
- 2022-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a duplicate cleaning line and an update from manual operation to automatic operation.