PMA P860004S389
- Device
- SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S389
- Product code
- LKK
- Decision date
- 2022-05-05
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Changes to bacterial endotoxin test procedure and addition of new incubator shaker.
Current openFDA PMA Record#
- Device
- SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S389
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2022-05-05
- Decision code
- OK30
- Date received
- 2022-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to bacterial endotoxin test procedure and addition of new incubator shaker.