PMA P860004S462
- Device
- SynchroMed™ Infusion System, Ascenda ™ Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S462
- Product code
- LKK
- Decision date
- 2026-10-16
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- for qualifying processes related to an internal component
Current openFDA PMA Record#
- Device
- SynchroMed™ Infusion System, Ascenda ™ Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S462
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2026-10-16
- Decision code
- OK30
- Date received
- 2026-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for qualifying processes related to an internal component