PMA P860004S443
- Device
- SynchroMed ™ Infusion System, Ascenda ® Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S443
- Product code
- LKK
- Decision date
- 2026-01-20
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- the use of a new manufacturing material
Current openFDA PMA Record#
- Device
- SynchroMed ™ Infusion System, Ascenda ® Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S443
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2026-01-20
- Decision code
- APPR
- Date received
- 2025-05-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the use of a new manufacturing material