PMA P080012S046
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S046
- Product code
- LKK
- Decision date
- 2017-09-11
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for changes to the Power and Prescription buttons of the Flowonix Prometra Patient Therapy Controller.
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S046
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2017-09-11
- Decision code
- APPR
- Date received
- 2017-06-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Power and Prescription buttons of the Flowonix Prometra Patient Therapy Controller.