- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S070
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-05-04
- Decision code
- OK30
- Date received
- 2021-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of additional detection controls for the pump tube O-ring assembly processes for the SynchroMed Infusion System and the Implantable System for Remodulin.