PMA P140032S064
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S064
- Product code
- LKK
- Decision date
- 2020-12-18
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- the update of the manufacturing execution system to FACTORYWorks Release 9.8
Current openFDA PMA Record#
- Device
- Implantable System for Remodulin
- Applicant
- Medtronic, Inc.
- PMA number
- P140032
- Supplement
- S064
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-12-18
- Decision code
- OK30
- Date received
- 2020-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the update of the manufacturing execution system to FACTORYWorks Release 9.8