- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S072
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-06-25
- Decision code
- OK30
- Date received
- 2021-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to the newly defined and characterized solder paste inspection (SPI) process at Medtronic Tempe Campus (MTC), Medtronic’s internal supplier of hybrids used in the manufacturing of Medtronic Neuromodulation (Neuro) products