PMA P860004S447
- Device
- SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S447
- Product code
- LKK
- Decision date
- 2025-08-28
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- process updates to feedthrough and hermetic testing operations, including leak testing
Current openFDA PMA Record#
- Device
- SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S447
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-08-28
- Decision code
- OK30
- Date received
- 2025-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- process updates to feedthrough and hermetic testing operations, including leak testing