PMA P860004S442
- Device
- SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- Product code
- LKK
- Decision date
- 2025-05-21
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- the replacement of a non-patient contacting wire drawing fluid (lubricant) used at a contract supplier
Current openFDA PMA Record
- Device
- SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S442
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2025-05-21
- Decision code
- OK30
- Date received
- 2025-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the replacement of a non-patient contacting wire drawing fluid (lubricant) used at a contract supplier